Respiratory secretion rentention device, system and method

ABSTRACT

An apparatus, system, and method for managing respiratory secretions and fluids in sections of artificial airways. A secretion removal assembly configured to connect to a respiratory secretion retention device, the respiratory secretion retention device adapted to fluidly connect to an artificial airway, the secretion removal assembly including a connector adapted to connect to a port of the respiratory secretion retention device; and a bag in fluid communication with the connector can be provided. In another aspect of this embodiment, the bag is adapted to collect the secretions that emit from the port of the respiratory secretion retention device. In yet another aspect of this embodiment, the secretion removal assembly further can include a tube having a first end and a second end opposite the first end, the first end in fluid communication with the connector and the second end in fluid communication with the bag.

RELATED APPLICATIONS

This application is a continuation of pending U.S. application Ser. No.12/882,162 filed Sep. 14, 2010 to Angelo Caruso et al., entitledRESPIRATORY SECRETION RETENTION DEVICE, SYSTEM AND METHOD, whichapplication is a continuation-in-part of pending U.S. application Ser.No. 12/648,033 filed Dec. 28, 2009 to Robert M. Landis, et al., entitledRESPIRATORY SECRETION RETENTION DEVICE, SYSTEM AND METHOD, whichapplication is a continuation-in-part of pending U.S. application Ser.No. 12/431,069 filed Apr. 28, 2009 to Robert M. Landis, et al., entitledRESPIRATORY SECRETION RETENTION DEVICE, SYSTEM AND METHOD, whichapplication claims benefit and priority from U.S. Provisional PatentApplication Ser. No. 61/104,597, filed Oct. 10, 2008, the entirecontents of all of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION Statement of the Technical Field

The present invention relates to artificial airways and moreparticularly to an airway device for controlling respiratory secretionsin artificial airways, and associated devices such as respiratory gasdelivery devices.

Discussion of the Related Art

The use of artificial airways is a common method of maintaining an openairway for patients who require some type of respiratory assistance.Artificial airways come in a variety of options depending on the patientand level of respiratory intervention required. Large numbers ofartificial airways have three common features. First, the artificialairway will be a flexible tube that extends into the patient's trachea.Second, most artificial airways will have an inflatable cuff near thedistal end of the tube. The inflatable cuff can be used to make anairtight seal, e.g., for nasal tracheal, oral tracheal and tracheostomytubes where the entire breath of the patient is directed through thetube. Third, the standard artificial airway has a 15 mm fitting on theexternal opening of the tube to which respiratory gas delivery devicesand instruments can be attached compliant with the ISO 5356; Anestheticand Respiratory Equipment—Conical Connectors standard.

One of the common issues with having the patient breathe through theseartificial airways is that respiratory secretions, which would normallyenter the pharynx and be swallowed, expectorated or coughed out throughthe mouth, are forced to egress through the lumen of the artificialairway. The presence of the tube, being a foreign object in the airwaycan also stimulate respiratory secretions.

Keeping the tube and airway clear of secretions is a procedure performedby clinicians, which requires training and vigilance. Depending on thecondition of the patient, the frequency of clearing the airway with asuction catheter varies greatly. When secretions accumulate in the tubethere is added resistance to breathing and when the patient is strongenough, a forceful exhalation sends the secretions out through the tubeand into the room or into any device attached to the tube.

Some fluid trap devices for use between an artificial airway andrespiratory gas delivery devices, such as a ventilator circuit, have afill volume substantially independent of orientation of the trap withinthe fluid circuit. Such fluid trap devices are disadvantageous as theyimpose unnecessary and excessive dead-space (e.g., exhaled air that isre-breathed) to achieve the independent orientation.

Typically, when a ventilator circuit or an instrument is detached froman artificial airway, the patient coughs and respiratory secretions andfluids are sprayed into the room. In addition, it is common for apatient on a ventilator to have secretions accumulate inside anartificial airway, such as endotracheal (ET) tube, with no place to gobut up the tube, down the tube or into whatever breathing instrument isattached to the ET tube.

In the last decade, the use of “closed suction” devices with ventilatorbreathing circuits has become a standard at many medical facilities. Aclosed suction device allows for access to the airway with a suctioncatheter without detaching or removing the treatment device from theartificial airway. Closed suction systems add additional support toclinicians by greatly reducing the time and effort necessary forclearing the airway. A closed suction device for example, can allow acatheter to advance into the artificial airway for suctioning and thenbe withdrawn into a protective sheath where it is protected fromcontamination when the catheter is not in use. The closed suctioncatheter may be used multiple times without opening the device to theatmosphere, and is usually used for one to several days. A closedsuction system allows access to the ventilator breathing circuitconnected with the patient to remain “closed” as opposed to methods thatrequire it to be “opened” to the atmosphere for access. Closed suctionalso reduces risk of microbial contamination of the artificial airwayduring suctioning thereby protecting the patient's airway frominfection. In numerous medical institutions, the infection controldepartments have made the use of closed suction a standard of practiceby requiring that all intubated patients in the intensive care unit(ICU) have a closed suction system installed.

Most clinicians find that there are a significant number of instanceswhen it is necessary to detach a ventilator circuit or respiratoryinstrument (i.e. “open the circuit”), and having protection from patientsecretions entering the environment during these occasions is mostdesirable.

There are three main problems with secretions in the tube of anartificial airway. First, when the ventilator circuit is disconnected,secretions can be sprayed into the room if the patient coughs. Second,secretions in the artificial airway result in compromised breathing.Third, when secretions are forced out into the attached ventilatorcircuit, these secretions can foul the attached instruments, such as aheat and moisture exchange (HME) device, and the like.

SUMMARY OF THE INVENTION

Embodiments of the present invention address deficiencies of the art inrespect to artificial airways and respiratory secretions management andprovide a novel and non-obvious apparatus, system, and method formanaging respiratory secretions and fluids in a section of an artificialairway, ventilator circuit system. In an embodiment of the invention, asecretion removal assembly configured to connect to a respiratorysecretion retention device, the respiratory secretion retention deviceadapted to fluidly connect to an artificial airway, the secretionremoval assembly including a connector adapted to connect to a port ofthe respiratory secretion retention device; and a bag in fluidcommunication with the connector can be provided. In another aspect ofthis embodiment, the bag is adapted to collect the secretions that emitfrom the port of the respiratory secretion retention device. In yetanother aspect of this embodiment, the secretion removal assemblyfurther can include a tube having a first end and a second end oppositethe first end, the first end in fluid communication with the connectorand the second end in fluid communication with the bag.

In another embodiment of the invention, a respiratory secretion removalsystem can be provided. A respiratory secretion removal system caninclude a respiratory secretion retention assembly, the respiratorysecretion retention assembly adapted to fluidly connect to an artificialairway and a secretion removal assembly, wherein the secretion removalassembly comprises a collection bag.

In another embodiment of the invention, a secretion removal assemblyconfigured to connect to a respiratory secretion retention (RSR) devicecan be provided. The secretion removal assembly can include a connectorconfigured for connecting to a sealed port of the respiratory secretionretention device, where the connector is configured to first engage theport in a non-sealed area of the port prior to one of breaching,engaging and repositioning of the seal of the port of the respiratorysecretion retention device.

In yet another embodiment of the invention, a secretion removal assemblyconfigured to connect to a respiratory secretion retention (RSR) devicecan be provided. The secretion removal assembly can include a connectorconfigured for connecting to a port of the respiratory secretionretention device, where the port has a first seal and the connector isconfigured to create a second seal with the port prior to orsimultaneously to one of breaching, engaging and repositioning of thefirst seal of the port of the respiratory secretion retention device.

In yet another embodiment of the invention, a secretion removal assemblyconfigured to connect to a respiratory secretion retention (RSR) devicecan be provided. The secretion removal assembly can include a connectorconfigured for connecting to a port of the respiratory secretionretention device, where the connector is configured to first engage theport in a non-sealed area of the port prior to one of breaching,engaging and repositioning of the seal of the port of the respiratorysecretion retention device.

In an embodiment of the invention the RSR device may include a port forinstilling fluids, such as saline or medication. Medication may beaerosolized for delivery of medication to the airway.

In still another embodiment of the invention, a respiratory secretionretention (RSR) device configured to connect to an artificial airway canbe provided. The respiratory secretion retention (RSR) device caninclude a housing that defines a passageway for the flow of respiratorygases, a chamber that is defined by the housing, where a portion of thechamber is configured to retain exhaled respiratory particulate andliquid, and an expiratory port of the housing, wherein the expiratoryport is not parallel to a gas delivery port of the housing during somephase of use of the device. In an aspect of this embodiment, the housingis configured to provide for repositioning of the gas delivery port withrespect to the expiratory port.

The device can include a housing that defines a passageway for the flowof respiratory gases with at least two chambers coupled to the housing.The chambers are configured to retain exhaled respiratory particulateand liquid. The respiratory secretion retention further including apatient port coupled to the housing that is in fluid communication withthe artificial airway and a repositionable barrier configured to isolateat least one of the two chambers from the passageway.

In another embodiment, a secretion removal assembly can connect to arespiratory secretion retention device; the secretion removal assemblycan include a connector configured for connecting to a port of therespiratory secretion retention device and a spike coupled to theconnector. In another aspect of this embodiment, the spike is configuredfor one of breaching, engaging and repositioning of a seal of the port.

Additional aspects of the invention will be set forth in part in thedescription which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. The aspectsof the invention will be realized and attained by means of the elementsand combinations particularly pointed out in the appended claims. It isto be understood that both the foregoing general description and thefollowing detailed description are exemplary and explanatory only andare not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute partof this specification, illustrate embodiments of the invention andtogether with the description, serve to explain the principles of theinvention. The embodiments illustrated herein are presently preferred,it being understood, however, that the invention is not limited to theprecise arrangements and instrumentalities shown, herein:

FIGS. 1A and 1B are schematic illustrations of the placement of an RSRdevice showing its attachment to an artificial airway in an intubatedpatient, where the RSR device is also connected to a ventilator circuitin FIG. 1A and wherein an RSR device is connected to a closed suctioncatheter in FIG. 1B;

FIGS. 2A and 2B are schematic illustrations of an RSR device accordingto a certain embodiment of the present invention;

FIGS. 3A and 3B are cross-sectional schematic illustrations of yetanother RSR device according to a certain embodiment of the presentinvention;

FIGS. 4A, 4B and 4C shows cross-sectional schematic illustrations of yetanother RSR device according to a certain embodiment of the presentinvention;

FIGS. 5A, 5B and 5C shows schematic illustrations of yet another RSRdevice according to a certain embodiment of the present invention;

FIGS. 6A, 6B and 6C shows schematic illustrations of details of variousforms of diverters which may be utilized in the RSR device according tovarious embodiments of the present invention;

FIGS. 7A and 7B shows schematic illustrations of yet another RSR deviceaccording to a certain embodiment of the present invention;

FIGS. 8A and 8B shows additional schematic illustrations of the RSRdevice shown in FIGS. 7A and 7B according to a certain embodiment of thepresent invention;

FIG. 9 shows cross-sectional schematic illustrations of variations ofthe RSR device shown according to a certain embodiment of the presentinvention;

FIGS. 10A and 10B shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 11A, 11B and 11C shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 12A, 12B and 12C shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIG. 13A shows lateral schematic view of a configuration of an RSRdevice shown according to a certain embodiment of the present invention;

FIG. 13B shows a frontal schematic view of the RSR device shown in FIG.13A;

FIG. 14 shows a cross-sectional schematic illustration of the RSR deviceaccording to a certain embodiment of the present invention;

FIGS. 15A, 15B and 15C shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 16A, 16B and 16C shows cross-sectional schematic illustrations ofvariations of the RSR device according to a certain embodiment of thepresent invention;

FIGS. 17A and 17B shows front schematic illustrations of variations ofthe RSR device shown according to a certain embodiment of the presentinvention;

FIGS. 18A, 18B and 18C shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 19A, 19B and 19C shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 20A and 20B shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIG. 21 shows a cross-sectional schematic illustration of variations ofthe RSR device shown according to a certain embodiment of the presentinvention;

FIGS. 22A and 22B shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 23A and 23B shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 24A and 24B shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 25A and 25B shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 26A, 26B and 26C shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 27A and 27B shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIG. 28 shows a cross-sectional schematic illustration of variations ofthe RSR device shown according to a certain embodiment of the presentinvention;

FIGS. 29A, 29B and 29C shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 30A, 30B and 30C shows cross-sectional schematic illustrations ofvariations of the RSR device shown according to a certain embodiment ofthe present invention;

FIGS. 31A, 31B, 31C and 31D shows cross-sectional schematicillustrations of variations of the RSR device shown according to acertain embodiment of the present invention;

FIG. 32A shows perspective schematic illustrations of variations of theRSR device shown according to a certain embodiment of the presentinvention;

FIG. 32B shows a cross-sectional schematic illustration of the RSRdevice shown in FIG. 32A according to a certain embodiment of thepresent invention;

FIG. 33A illustrates another embodiment of an RSR device according to acertain embodiment of the present invention;

FIG. 33B shows a cross-sectional schematic illustration of the RSRdevice shown in FIG. 33A in an assembled stage according to a certainembodiment of the present invention;

FIG. 33C is a partial longitudinal cross-sectional view of anonassembled RSR device taken along the plane labeled A-A shown in FIG.33B;

FIGS. 33D and 33E show cross-sectional views of an RSR device in aninitial sealing connection position and a final sealing connectionposition;

FIGS. 34A and 34B shows schematic illustrations of variations of the RSRdevice according to a certain embodiment of the present invention;

FIG. 35A is a partial longitudinal cross-sectional view of a nonengagedRSR device according to a certain embodiment of the present invention;

FIGS. 35B and 35C show cross-sectional views of an RSR device in aninitial sealing connection position and a final sealing connectionposition;

FIGS. 36A and 36B show cross-sectional views of an RSR device in aninitial sealing connection position and a final sealing connectionposition;

FIGS. 37A and 37B show cross-sectional views of an RSR device in ainitial nonengaged position and a final engaged position according to acertain embodiment of the present invention;

FIG. 38A illustrates another embodiment of an RSR device shown accordingto a certain embodiment of the present invention;

FIG. 38B is a partial longitudinal cross-sectional view of a retentionassembly taken along the plane labeled A-A shown in FIG. 38A;

FIG. 38C is a partial longitudinal cross-sectional view of an assembledRSR device taken along the plane labeled A-A shown in FIG. 38A;

FIG. 39 illustrates a cross-sectional cutaway view of another embodimentof an RSR device shown according to a certain embodiment of the presentinvention;

FIG. 40 shows schematic illustrations of variations of the RSR deviceshown according to a certain embodiment of the present invention;

FIG. 41A shows schematic illustrations of variations of the RSR deviceshown according to a certain embodiment of the present invention;

FIG. 41B is a cross-sectional view of the RSR device shown in FIG. 41A;

FIG. 42A shows schematic illustrations of variations of the RSR deviceshown according to a certain embodiment of the present invention;

FIG. 42B is a cross-sectional view of the RSR device shown in FIG. 42A;

FIG. 43A shows schematic illustrations of variations of the RSR deviceshown according to a certain embodiment of the present invention;

FIGS. 43B and 43C illustrate cross-sections along lines 43-43 throughthe patient port from a top view of the RSR device shown in FIG. 43A;

FIG. 43D illustrates an alternate method of secretion clearance orremoval from RSR device of FIG. 43A;

FIG. 44A shows schematic illustrations of variations of the RSR deviceshown according to a certain embodiment of the present invention;

FIG. 44B shows a cross-sectional perspective view taken through planeB-B of RSR device of FIG. 44A in an assembled state;

FIG. 44C is a perspective view of a plug of RSR device of FIG. 44A thatillustrates some channels; and,

FIGS. 44D, 44E, and 44F illustrate partial cross-sections of an RSRdevice of FIG. 44A in non-engaged, partially engaged, and fully engagedpositions respectively.

DETAILED DESCRIPTION OF THE INVENTION

During the exhalation phase of respiration, fluid is expelled from thelower respiratory tract. Most of the fluid is in the form of gases, butliquid and particulate matter (respiratory secretions) are alsoexpelled. The RSR acts to separate the “respiratory secretions” from therespiratory gasses. For purposes of this disclosure, “respiratorysecretions” may include sputum, mucus, mucus plugs, and/or other allother nongaseous matter which may be conveyed out of the lowerrespiratory tract and the like.

Embodiments of the present invention address deficiencies of the art inrespect to artificial airways and respiratory secretion management, andprovide a novel and non-obvious apparatus, system, and method formanaging respiratory secretions and fluids in artificial airways. Forpurposes of this disclosure “artificial airway” may include any portionof the breathing conduit that connects to a patient's airway. In anembodiment of the invention, a Respiratory Secretion Retention (RSR)device for connecting to an artificial airway can be provided. Arespiratory secretion retention device configured for connecting to anartificial airway comprising a housing that defines a passageway for theflow of respiratory gases, a chamber defined by the housing with aportion of the chamber configured to retain exhaled respiratoryparticulate and liquid, a patient port defined by the housing, which isin fluid communication with an artificial airway and at least one accessport configured to provide access to the chamber and the patient port.In another aspect of this embodiment, the at least one access port caninclude a control valve, the control valve located in a downstreamposition of a passage of the access port to control access from theaccess port to the chamber.

In another embodiment of the invention, a respiratory secretionretention (RSR) device can include a housing that defines a passagewayfor the flow of respiratory gases, a chamber defined by the housing witha portion of the chamber configured to retain exhaled respiratoryparticulate and liquid, a patient port defined by the housing, which isin fluid communication with an artificial airway, a suction tubesubassembly coupled to the housing, which defines a medical instrumentpassage and a suction tube portion and at least one access portconfigured to provide access to the chamber and the patient port. Inanother aspect of this embodiment the suction tube subassembly iscoupled to a knob that provides for translation repositioning of thesuction tube subassembly with respect to the housing.

In yet another embodiment of the invention, a respiratory secretionretention (RSR) device configured for fluidly connecting to anartificial airway can be provided. The respiratory secretion retention(RSR) device can include a housing that defines a passageway for theflow of respiratory gases, a chamber defined by the housing with aportion of the chamber configured to retain exhaled respiratoryparticulate and liquid, a patient side port coupled with the housing,which is in fluid communication with an artificial airway, at least oneaccess port configured to provide access to the chamber and the patientport and a tube coaxially aligned and coupled to the access port and thepatient port, to define a passage between the access port and thepatient port. In another aspect of this embodiment, the tube includes adiverter in the passage. In yet another aspect of this embodiment, thediverter is rotatably hinged on a wall of the tube. In still yet anotheraspect of this embodiment, the RSR device can include a sleevesurrounding the tube that includes at least one first aperture and thetube includes at least one second aperture.

In illustration, FIG. 1A is a schematic illustration of an RSR device200 attached to an endotracheal (ET) tube 102 in an intubated a patient110. The RSR device 200 also can be attached to a ventilator circuit104. The patient 110 is shown at an approximately 45-degree angle fromlevel as this position as recommended by the Centers for Disease Control(CDC) for prevention of ventilator associated pneumonia. Thisillustration shows the relationship of the RSR device 200 used inassociation with a ventilator circuit 104. The device can also be usedin association other ventilation tubes such as with a tracheostomytubes, pharyngeal airway, or nasotracheal tubes. RSR 200 can be usedalone with an artificial airway 102 without a ventilator 104, such as ina spontaneously breathing patient.

FIG. 1B illustrates a closed suction device 106 that can be connectedbetween the RSR device 400 and the ventilator circuit 104. Certainembodiments of the present invention allow for the use of closedsuction, and allow a suction catheter 108 of the closed suction device106 to pass through RSR device 400 and into and through the patient'sartificial airway in accordance with an embodiment of the presentinvention.

FIG. 2A is a schematic illustration of an RSR device 200 showing detailof its attachment to the endotracheal tube 102 and to the ventilatorcircuit. The RSR device can be applied so that gravity pulls secretionsinto a dependent area of the housing configured to retain therespiratory secretions. In embodiments, swivels can be added to the RSRto articulate the device in order to adjust it into a dependent positionwith respect to the collection of respiratory secretions, so thatgravity pulls the secretions into a dependent area of the housingconfigured to retain the respiratory secretions.

The typically male fitting of the artificial airway 102 (as illustratedin FIG. 2A) fits into the typically female 15 mm fitting 202 which inpreferred embodiments of this invention is configured as a swivelfitting. The rotation of this fitting is indicated by arrow 204. Fitting202 can be connected to the RSR main body 206 with tube 208. Tube 208can be straight or tube 208 may be angled and/or rotatable. A secondtube 210 can be located on the ventilator side of the RSR device 200.Tube 210 can be straight or tube 210 can be angled and rotatable. Inembodiments, tube 208 and tube 210 can swivel to allow the reservoirarea of main body 206 to be placed in a dependent orientation whileallowing the patient to be placed in a variety of positions. RSR device200 can be designed to be used where its reservoir area 212 is placedbelow the artificial airway 102. Arrows 214 show the possiblearticulation of the angled and rotatable tubes in one embodiment inrelation to the main body 206. Tube 210 is shown connected to a femaleventilator connection 216 which also can contain a swivel. Thus, themain body 206 of the RSR 200 may move in two axes and the reservoir area212 can be oriented in a dependent position with respect to gravity.

FIG. 2B further illustrates the air flow path of RSR device 200,illustrating its function. When the patient exhales, the flow entersconnector 202 through the artificial airway into the RSR device 200 asshown by arrow 218. The momentum of the heavier fluids (respiratorysecretions) causes them to both impact the interior surfaces of the RSRdevice and to fall out of the gas flow when the flow channel widens inthe RSR and gas flow slows. This occurs in the RSR main body 206, andflow is indicated by arrows 220 and 222. Outflow of expiratory gasses isshown by arrows 224. On inhalation the gases reverse the flow directionin this embodiment of the invention. A fluid level of trappedrespiratory secretions 226 is shown.

FIG. 2B shows RSR device 200 according to an embodiment of thisinvention which allows for control of the orientation of the reservoirarea for collection of respiratory secretions. In order to retain thesecretions, it is important that these secretions are unlikely to exitthe reservoir area of the main housing 206 and unlikely to drain backinto the patient's airway. Thus the ability to position the reservoir ina dependent orientation is an important feature of this invention. Asthe patient may be moved, it is advantageous to have a device whichallows the orientation of the reservoir to move without disconnectingthe device which would open the airway and allow possible contaminationof the airway. A sputum trap that is insensitive to orientation has thedisadvantage of an increased dead air space, and thus creates an addedburden for CO2 removal during respiration.

FIG. 3A illustrates others embodiment of an RSR device according to anembodiment of the present invention. In FIG. 3A, RSR device 300 is shownas a cross-sectional schematic. Patient airway port 302 allows forconnection to artificial airway 102 typically with a 15 mm maleconnector via swivel connector 304. Ventilation source port 306 is shownwith a 90 degree angled arm 308, which can rotate according to oneconfiguration of the present invention, and is shown linked to acorrugated tubing 310 via swivel fitting 312. Ventilation source port306 also can have a swivel.

Suction access ports 314 and 318 are plugged when not in use, as shownby plug 320 which seals port 318 in FIG. 3A, and plug 322 sealing port314 in FIG. 3B. Access port 314 allows for the introduction of a suctioncatheter 316 that may suction the artificial airway 102 as illustratedin FIG. 3A, or may be used for the introduction of another instrumentsuch as a bronchoalveolar lavage tube. Access port 318 allows forintroduction of a suction catheter 316 as shown in FIG. 3B or for theintroduction of another instrument such as a needle for example forremoval of collected respiratory secretions which may collect in thereservoir area 324. In a variation of this device (such as described inFIG. 11A) a fitting for closed suction may be attached. Swivelconnectors 304 and 312 allow for control of orientation of the RSRdevice 300.

FIGS. 3A and 3B also illustrate spill guards 326, which extend from theinner wall of the RSR device 300, and help prevent unintended emptyingof the liquid contents of the reservoir back into the artificial airwayor into the gas delivery limb in the case of movement or change inposition.

FIGS. 4A, 4B and 4C show cross-sectional schematic illustrations ofanother RSR device according to a certain embodiment of this invention,and each illustration shows a different conformational position of RSRdevice 400.

FIG. 4A is a cross sectional view of an RSR device 400 having a 3sections which can rotate in reference to each other. RSR device 400includes a patient interface section 402, a middle section 404 with adiverter 408, and a ventilation source section 406. FIG. 4A shows RSRsections 402, 404 and 406 in their typical use conformationalorientation. RSR device 400 changes its conformation by changing therotation positions of the sections 402, 404 and 406. RSR device 400 isconfigured so that the interior walls form a gas flow chamber, and areservoir area for retained respiratory secretions.

The diverter 408 is configured to redirect the gas flow and to separaterespiratory secretions that may be expelled during exhalation. Diverter408 is disposed substantially perpendicular to the inflow path of theartificial airway 102. The diverter acts as an obstacle in theexpiratory fluid pathway. As the respiratory secretions have more mass,and thus more momentum, they do not flow around the tortuous flow pathcreated by the diverter as easily as the lighter gases in theexhalation, and are more likely to impact the surface of the diverterand the interior of the housing, to lose velocity and thus be separatedfrom the gas flow. The fluid flow through the RSR devices also slows asa result of the widening of the cross-section of the flow path withinthe housing where the flow chamber is formed. This also decreases themomentum and acts to separate the respiratory secretions from the gasesin the exhalation, and helps to retain these secretions within thechamber. A simplified gas flow path for the RSR device 400 when in thetypical use position is illustrated by arrow 410.

The orientation of the reservoir area 418 helps retain the heavierfluids in the body of the RSR device 400. A fluid line 420 is shown tohelp illustrate fluid in the reservoir area. The dependent area 418forms a reservoir for respiratory secretions. Swivel 412 in artificialairway port 424 allows for orientation of the RSR in relation to theartificial airway 102. An RSR device may also be configured with aswivel on the ventilator source section; however a swivel is not usuallyrequired on the ventilation source end of the RSR device 400 where itattaches to ventilation port 424 for use with a closed suction device106, as the closed suction device typically contains its own swivel 110.

Also illustrated are spill guards 414 and 416, which show that theinlets to the connection ports from the inner housing of the RSR areconfigured to prevent the efflux of the retained secretions. Spillguards 414 and 416 advantageously prevent respiratory secretions andliquids from leaving the RSR device 400 and entering the HME, thebreathing circuit and/or the artificial airway. Accordingly, the spillguards 414 and 416 help prevent egress of collected airway fluids intorespiratory instruments when the patient turns or moves for example, andmakes the device less susceptible to egress of retained fluids withmovement of the patient.

In FIG. 4B, middle section 404 is shown rotated 180 degrees in relationto the typical use conformational position of sections 402 and 406. Thisallows diverter 408 to move out of a direct path between the ventilationsource port 422 and the artificial airway port 424. As furtherillustrated in FIG. 4B, this conformational positioning allows thesuction catheter 108 of the closed suction device 106 attached to theventilation source port 422 to be advanced through the body of RSR 400and into the artificial airway 102 for suctioning. After suctioning ofthe artificial airway, catheter 108 can be withdrawn into the closedsuction device 106 and the RSR device 400 can be returned to it typicaluse conformational alignment. Other instruments such as a bronchialalveolar lavage device may also be passed through the RSR device in asimilar manner.

In FIG. 4C, the ventilation source section 406 of RSR device 400 isshown rotated 180 degrees with relation to the typical use position ofsections 402 and 404. This allows the suction catheter 108 of the closedsuction device 106 to be advanced into the reservoir area 418 of thebody of RSR device 400 for suctioning and evacuation of retained fluids.After clearing the retained respiratory secretions from the reservoirarea, catheter 108 can be withdrawn into the closed suction device 106and the RSR device 400 can be returned to it typical use positionconformational alignment.

FIG. 5A is a schematic illustration of another RSR device according to acertain embodiment of this invention that illustrates a diverter 506placed in the path of the gas flow, which allows for the passage of asuction catheter through the diverter 506. The arrow 508 in FIG. 5Ashows the flow pattern of respiratory gasses through the chamber formedby the housing of RSR device 500 when it is in its typicalconformational position for use for retaining respiratory secretionsfrom exhaled respiration. Respiratory secretions are indicated by fluidline 510 where the housing of RSR device 500 acts as a reservoir area.The housing of device 500 has two main chamber sections. The patientinterface section 502 is on the artificial airway side, and theventilation source section 504 is on the ventilation source side. Thesetwo sections may have a circular cross section and are configured sothat they are rotatably connected to one another.

In FIG. 5A section 502 is shown with a respiratory gas diverter 506attached to a portion of the inner wall of device 500. Diverter 506features an orifice 512. Orifice 512 is shown with a funnel shape whichcan act as an instrument guide for helping pass an instrument, such assuction catheter (108) through this orifice as shown in FIG. 5B. A valve514, shown here as a flap valve, closes orifice 512 and limitsexpiratory flow from passing through the orifice 512, but allows thepassage of an instrument as shown in FIG. 5B. In alternativeembodiments, a valve may not be required as orifice 512 may be sizedsmall enough such that it limits the passing of expiratory flows andsecretions

FIG. 5B illustrates RSR device 500 during the use of an instrumentintended to enter the artificial airway. Valve 514 is shown in the openposition, held open by suction catheter instrument 108, extending from aclosed suction device 106. Other instruments such as a bronchialalveolar lavage catheter may also be used.

FIG. 5C illustrates RSR device 500 in a second conformational position.The two main chamber sections 502 and 504 are shown rotated 180 degreesin relationship to each other. This conformational arrangement allowsthe suction catheter 108 to be used to remove retained fluids and otherrespiratory secretions from the RSR device 500 which have collected inthe reservoir area.

FIG. 5B further illustrates spill guards 518 and 520, which can beincluded in RSR devices according to certain configurations of thisinvention. The spill guards 518, 520 advantageously prevent respiratorysecretions and liquids from leaving the RSR device 500 and entering theHME, breathing circuit, or the patient's artificial airway. Accordingly,the spill guards 518 and 520 help prevent egress of collected airwayfluids into respiratory instruments or into the artificial airway, forexample when the patient turns or moves. FIG. 5C also marks a swivel 522in the artificial airway port connector.

FIGS. 6A, 6B and 6C show schematic illustrations of various additionaldesigns for diverters which allow for the passage of a suction catheterthrough the diverter portion of RSR devices according to certainconfigurations if this invention. FIG. 6A shows a cross-sectionalillustration of a two-stage diverter. A first stage 602 of the diverter600 is on the artificial airway port side of the diverter. Multipleslits 604 are shown perforating the first stage 602 of the divertershown in the configuration of a star shaped, although various forms maybe used within the concept of this invention. The first stage 602 may bethin at the center to decrease resistance and help guide passage of aninstrument such as a suction catheter through the first stage. The firststage may use material which is flexible and allow deformation so thatwedged shaped areas 606 formed by the perforations can bend out of theway of an instrument being passed through this stage of the diverter.The first stage 602 of the diverter 600 can be replaced with a simpleflap 514, as is shown in FIG. 5A.

Diverter 600 has a second stage 608. Second stage 608 may have a largerouter diameter than the first stage 602 to enlarge the area ofrespiratory gas flow diverted. The second stage 608 of the diverter 600is on the ventilation source side of a RSR device Second stage 608 mayhave a funnel shape which can act as a guide for directing aninstrument, such as a suction catheter, through the diverter.

FIG. 6B shows a diverter 610 with a star-shaped perforation. Othershapes, sizes and patterns of perforations could be utilized indifferent embodiments. FIG. 6C illustrates a diverter 620 with a funnelshaped outer ring 622, and a hinged flap valve 624. This diverter outerring can have a sloped wall 622, which can help guide an instrument.These illustrations are not meant to in any way limit the type ofdiverter, which may be used to divert secretions or which can be used toallow an instrument to pass through this area of the RSR device, butrather to show some of the possible configurations. A diverter may haveone or more stages and the stages may be of similar or differentdesigns.

FIGS. 7A, 7B, 8A and 8B are schematic illustrations constructed inaccordance with a further embodiment of the present invention showing anRSR device which allows conformational changes of the device.

FIG. 7A shows a perspective view of a configuration of anotherembodiment of the invention. RSR device 700 has a connector 710 whichallows connection to an artificial airway port and a connector 720 thatallows connection to a ventilation source. In a preferred configurationthese connectors are standard 15 mm respiratory connectors. Inembodiments, connector 710 is a female 15 mm swivel fitting andconnector 720 is a male 15 mm fitting which can accept connection to aclosed suction device or to a ventilator circuit. RSR device 700 has aventilation housing 705. Housing 705 has a reservoir portion 750 forcollecting secretions. Reservoir 750 can be integral to housing 705 or aseparate component. Reservoir 750 may be suctioned through theventilation housing or may be suctioned through a separate port in thereservoir itself. In embodiments, housing 705 can be flexible by beingconstructed of a non-rigid material, having thin walls, or by othermeans known to achieve flexibility. A flexible ventilation housingallows for a conformational change in terms of the alignment of theconnector 720 with certain other parts of the structure of the RSRdevice 700. This conformational change may be achieved through methodssuch as rotation, bending, translation, etc. A bellows area 715 in theventilation housing 705 is shown as a way to implement a conformationalchange.

FIG. 7A RSR device 700 can include a support structure 725. Supportstructure 725 can interface with connector 710, connector 720 and/orventilation housing 705. Support structure 725 can be integral to one ofthese components, such as connector 710. In embodiments, supportstructure 725 can contain a track 736 for interacting with key 735 toallow the RSR device 700 to be held in at least two differentconformational positions. Key 735 may extend from connector 720 on asupport arm 740. Key 735 can move through track 736. In anotherembodiment, a key feature or its mating detail in the support structure725 can deflect to allow for movement and placement into differentconformational positions. Various techniques such as tracks, snaps,ratchets, detents, etc. are known for maintaining conformationalpositions. Support structure 725 also can have a cage 730. Cage 730 canprotect a reservoir portion 750 of the housing 705 from inadvertentcompression, while allowing for compression with finger pressure, forexample, when desired by the user to help evacuate the contents of thereservoir 750.

FIG. 7A shows RSR device 700 in a straight position, which would be usedwhen the device is in normal use, and during suctioning of theartificial airway with a closed suction unit, or when introducing aninstrument into the artificial airway as shown in a cutaway view in FIG.7B.

FIG. 8A shows device 700 in a secondary position. In the secondaryposition, the control key 735 is in a secondary position and the bellowsarea 715 section of ventilation housing 705 is in a flexed position.This secondary position allows a suction catheter to be inserted intothe reservoir area 750 for evacuation of the pooled secretions as shownin FIG. 8B. The reservoir area 750 may be made of a flexible materialand may be squeezed by the operator during suctioning to help removecollected respiratory secretions.

FIG. 7B shows a cutaway view of RSR device 700. The catheter 108 can beseen supported by instrument guide 760, and passing through the secondstage 608 of diverter 600, which also acts as an instrument guide due toits funnel like shape. The catheter then passes through the first stage602 of the diverter 600 which acts as a valve, diverting respiratorysecretions when closed but allowing passage of the instrument.

FIGS. 8A and 8B show the position for the RSR device in a secondaryconformational position for use during suctioning of the reservoir.

FIG. 8B illustrates the RSR device 700 in a cross-sectional view in asecondary conformational alignment which may be used to removerespiratory secretions 820 from reservoir 750 using an instrument suchas closed suction catheter 108. Catheter guide 760 can help guide aflexible instrument.

FIG. 9 is a cross-sectional schematic illustration in accordance with acertain embodiment of the present invention configured with a connector920 shown as a Christmas tree or male barbed connector, for connectiondirectly to an endotracheal tube 930. The connector 920 may also connectto the endotracheal tube without the barbs. This configuration replacesthe fitting commonly used as the attachment to artificial airway asshown herein in other illustrations, for example the male fitting ofartificial airway 102 and port 302 as illustrated in FIG. 3A. Aconnector such as shown in FIG. 9 allows the RSR device to be integratedas a single unit with the patient artificial airway. FIG. 9 alsoillustrates that connector 920 can act as a swivel within housingsection 925 which allows the device to be rotated in relation to theendotracheal tube. This allows for positioning of the reservoir area ofthe RSR in a dependent orientation, and also decreases the strain andtraction of the artificial airway upon the patient.

In other embodiments, the RSR device 900 can be directly attached to atracheotomy tube, as RSR device 900 functions to replace the adapterthat is standard with ET and tracheotomy tubes. In embodiments, RSRdevice 900 can be packaged and sterilized with the artificial airways.

FIGS. 10A and 10B are yet other schematic illustrations of RSR deviceembodiments according to the present disclosure where the respiratoryinflow tract enters at the patient end of the RSR device, and theexhaled gasses pass through the RSR device. This has the added advantageof greatly reducing the volume of dead air space while still providing alarger reservoir. This inspiratory bypass that allows a larger reservoirarea, and can be used alone or in combination with valves to preventefflux of respiratory secretions back into the airway. FIG. 10Aillustrates an RSR device 1000 similar to device 200 shown in FIG. 2A.FIG. 10B illustrates an RSR device 1060 similar to RSR device 500. InFIG. 10A, the gas supply enters through delivery port 1020 close to theartificial airway. In device 200, the gas flow is bi-directional andreverses direction during the respiratory cycle. In contrast, in device1000 flow though the RSR body passes in one direction; away from thepatient. Arrow 1015 illustrated the direction of delivery of respiratorygas to the subject from the delivery arm of the ventilator circuit.During expiration breath passes through the RSR device 1000 as shown byarrow 1025 and into the exhalation arm of the ventilator circuit.

In FIG. 10B, the gas supply enters the RSR device through delivery port1020 and flows to the subject near to the artificial airway 102 as shownby arrow 1055. In similar device 500, the gas flow is bi-directional andreverses direction during the respiratory cycle. In contrast, in RSRdevice 1050, flow thought the RSR body passes in one direction; awayfrom the patient, as shown by arrow 1065, and flows towards expiratoryport 1010.

Another advantage to having a gas inflow tract on the patient side isthat if the reservoir side is opened for suctioning, negative pressureis unlikely to occur, and there is less likelihood of patientcontamination from the environment. Alternative to having a patient endinflow port configured integral into the RSR, a Tee can be added on thepatient end which is placed between the artificial airway and the RSRdevice. A disadvantage of this that the suction catheter must beextended further to suction the artificial airway.

FIGS. 11A and 12A illustrate additional embodiments of the currentinvention, wherein closed suction allows clearance of respiratorysecretions from the artificial airway and from the RSR device. FIG. 11Ashows a RSR device 1100 with an integrated closed suction catheter. InRSR device 1100, a suction catheter 1116 can be connected by a fitting1114. Fitting 1114 allows the suction catheter 1116 to be advanced andwithdrawn into and through the body 1122 of RSR device 1100. Fitting1114 also can pivot to allow the catheter 1116 to enter into theartificial airway for suctioning as shown in FIG. 11B or to enter thereservoir area 1118 for evacuation of accumulated respiratory secretionsfrom the RSR device as illustrated in FIG. 11C. Catheter 1116 is sealedwithin a protective sheath 1124, which is only partially visible inFIGS. 11A, 11B and 11C. Sheath 1124 is flexible and allows the catheterto be advanced into and retracted from the housing of the RSR device,and prevents contamination of the catheter from the externalenvironment.

FIG. 12A illustrates yet another embodiment of the invention showing anRSR device with an integrated fitting for a closed suction connection.Device 1200 is configured to attach to artificial airway 102 withconnector port 1202. A swivel connector, such as 1204 allows aconnection, which places less stress on the artificial airway. Stress onthe artificial airway may be injurious to the patient, may cause damageto the trachea, and may induce leaking of seal of the balloon of theendotracheal balloon. This may allow upper airway secretions to enterthe lung, which is considered to be a risk factor for ventilatorassociated pneumonia.

FIGS. 12A and 12B show a gas flow path diverter 1206. Diverter 1206contains a valve 1208 and bevels 1210 which act an instrument guide. Asuction catheter 108 is illustrated in FIG. 12B through the diverter.The diverter 1206 is shown as being supported by support arms 1212. Inother configurations, the diverter could be attached to an interiorwall, a swivel connector, or to the ventilation source side of the RSRdevice.

FIGS. 12B and 12C show device 1200 illustrated with a fitting 1214 toallow for connection to a closed suction device 106. The fitting 1214 isdesigned to allow flow of gas. Fitting 1214 can pivot to allow thecatheter 108 to enter into the artificial airway for suctioning as shownin FIG. 12B or to enter the reservoir area 1216 for evacuation ofaccumulated respiratory secretions from the RSR device 1200 asillustrated in FIG. 12C. The catheter 108 would be withdrawn into theclosed suctioning device during its typical use.

FIG. 13 illustrates yet another embodiment of an RSR device according tothe present invention. RSR device 1300 is configured to fit to atracheostomy tube 1350. A connector 1302, e.g., a swivel connector, isshown in FIG. 13A which allows orientation of the reservoir area 1320 ina dependent position for collection of respiratory secretions. Incontrast to having a single gas flow vent (e.g., exhalation port)configured to couple with another device, device 1300 is an example of aconfiguration of an RSR device with multiple perforations or vents 1304for direct flow to and from the device to the atmosphere. Vents areillustrated on the anterior surface, but can be on other surfaces. Theanterior and upper portion is shown containing heat and moistureexchange (HME) material 1306 which acts as a filter helping to protectthe patient's airway from airborne pathogens. The HME material also actsto capture heat and humidity from the patient's exhaled breath, andrelease it back to the patient upon inhalation, thus avoiding drying ofthe airways and avoiding energy loss from the patient. A large totalvent area is advantageous in that it provides low flow resistance andefficient heat and moisture exchange. FIG. 13B illustrates that withindevice 1300, an airflow diverter wall 1308 helps capture respiratorysecretions and guide them towards the reservoir area 1310 and towardsthe lower internal surface of the housing. Diverter wall 1308 helps toseparate respiratory secretions from the gas flow. RSR device 1300 alsohas spill guards 1312 which help retain secretions in the reservoir areaand help prevent spillage of retained respiratory secretions in theevent that the patient's position is moved.

The exhaled breath flows first towards the deflector and then flowsthrough the HME material 1306 where heat and moisture is captured andthe remaining exhaled gas can pass to the atmosphere through vents 1304.On inspiration, atmospheric gas enters through vents 1304 is filtered,heated and humidified before flowing into the patient airway.

The device in FIG. 13B shows an orifice 1318 with a cap 1314 on thefront surface of device 1300 which may be opened if suctioning isdesired. Deflector wall 1308 is illustrated in FIG. 13B with a valve1316 that allows a suction catheter or other instrument to be introducedinto the artificial airway 1350 with access being given by opening cap1314. In certain embodiments, RSR device 1300 may be configured so thata suction catheter or other instrument may be directed to enterreservoir area 1310. This allows for removal of respiratory secretionsfrom the device. In other configurations, the RSR device 1300 can beconfigured without these features.

Not shown in the illustration, the cap may cover a second valve at thesurface of the RSR device 1300. Such a valve would help prevent sputumfrom entering the room during suctioning, and limit inhalation ofunfiltered air. Valve 1316 can have, for example a conformation similarto valve 610 shown in FIG. 6B. In another embodiment, the device can bemade with a valve without a cap. In a configuration of the invention,one or more valves can be configured as an anti-asphyxiation valve whichwould open in the case that the resistance to flow through HME materialand surface vents became higher than desirable.

Device 1300 may be preferentially constructed with a housing made of aflexible material, such as silicone, to make wearing the device morecomfortable for the patient. The device may also be configured so thatit may be cleansed and the HME material or HME section may be replaced.

FIG. 14 illustrates another embodiment of an RSR device 1400 accordingto the present invention. Housing 1405 has a patient port 1420 forconnection to an artificial airway and a ventilation port 1430 forconnection to a closed suction device and/or ventilation source (notshown). The ports can have swivel connectors to facilitate orientationof the RSR device. Housing 1405 also has a reservoir 1450 for collectionof respiratory secretions. Opening 1490 allows secretions to enter thereservoir as they pass through the housing. The opening may be sizedlarge enough to maximize the entry of the secretions. Features such as adiverter, which were described in other embodiments of this invention,can also be located in RSR device 1400 to further separate secretionsfrom the gas flow and direct them into the reservoir. The RSR device1400 may be disposed of with the contained secretions, or the secretionsmay be removed by a variation of methods such as removing the reservoir,draining the reservoir, or suctioning the reservoir and/or housing, etc.In embodiments, the reservoir may be flexible. A flexible reservoir maybe collapsed, for example by squeezing, or translated into the housingin order to move the secretions into main section of the housing. Oncethe secretions are moved there, the secretions may be removed, forexample by a suction catheter 1410.

FIG. 15A illustrates a RSR device 1500 similar to RSR device 1400.Housing 1505 can include a diverter 1520 as shown. Housing 1505 furthercan include a flexible portion 1570 with a guide 1580. The flexibleportion 1570 can provide the guide to translate with respect to theinterior of the housing. In FIG. 15B, a suction catheter 1510 is shownpassing through the housing in order to suction an artificial airway ofa patient. In FIG. 15C, the guide is shown translated further into thehousing and therefore directing the suction catheter into a reservoir1550 in order to remove secretions.

FIG. 16A illustrates a RSR device 1600 similar to RSR device 1400.Housing 1605 has a diverter 1620 as shown. Housing 1605 has a guide 1680that can direct an instrument, such as a suction catheter, towards thediverter or towards a reservoir 1650. Guide 1680 can be integral tohousing 1605 or it could be a separate piece. If a separate piece, guide1680 may pivot within housing 1605 allowing for increased directionalcontrol of a suction catheter. A pivoting guide may extend through thehousing in a sealed manner to allow a user to externally control theangle of the guide. An external knob or similar detail could be attachedto the extended part of the guide to allow the user to pivot the guide.In FIG. 16B, a suction catheter 1610 is shown passing above the guide inthe housing in order to suction an artificial airway of a patient. InFIG. 16C, a suction catheter 1610 is shown passing below the guidedirecting the suction catheter into a reservoir 1650 in order to removesecretions.

FIGS. 17A and 17B illustrate another embodiment of and RSR device 1700according to the present invention. Housing 1705 has a patient port 1720for connection to an artificial airway and a ventilation port 1730 forconnection to a closed suction device and/or ventilation source (notshown). The ports may have swivels to facilitate orientation of the RSRdevice. Housing 1705 also has a reservoir 1750 for collection ofrespiratory secretions. The reservoir 1750 may be flexible or have aflexible extension, which allows the size of the reservoir to becontrolled. Features such as a diverter, which were described in otherembodiments of this invention, may also be located in the RSR device1700 to further separate secretions from the gas flow and direct theminto the reservoir 1750. A drain or vacuum port 1760 may be includedwhich allows for emptying the contents of the reservoir. In oneembodiment, a RSR device 1700 can include a drain port 1760 and a fluidinstillation port 1765. Instillation port 1765 can be used to instillsaline or other fluid to help clear the respiratory secretions whichhave collected in the reservoir, especially if these secretions arethick or tenacious.

A clip 1770 can be applied to the reservoir 1750 to divide the volume ofthe reservoir to an upper area 1752 above the clip 1770 and a lower area1754 below the clip 1770. A smaller reservoir volume is advantageous tolimit dead space volume, especially for example in smaller patients andin patients with certain respiratory diseases. A larger reservoir volumeis advantageous to allow for less frequent clearing of the secretions inthe RSR device 1700. The position of the clip 1770 may be adjustable onthe reservoir and therefore limiting the volume in the upper area 1752as desired by the user.

As shown in FIG. 17B, clip 1770 could be removed and then attached abovethe fluid instillation port 1765, allowing the reservoir to be clearedwhile maintaining a minimum deadspace in the upper area 1752,maintaining a closed air circuit, and preventing the patient fromexperiencing the effects of the clearing, such as with a vacuum. Whenthe reservoir 1750 begins to fill with respiratory secretions duringuse, the clip position may be adjusted to enlarge the upper area 1752.The clip 1770 also can be removed to allow the secretions to pool in thelower area 1754 of the reservoir, and then the clip may be reattached toagain limit the reservoir volume. The clip 1770 could then also be usedas a tool to force the secretions lower into the lower area 1754 of thereservoir. The secretions now in the lower area 1754 of the reservoirmay be drained through a port 1760 or may be maintained there until thedevice or reservoir is disposed.

Several other possible configurations of this invention can easily cometo mind by those skilled in the art, which are within the scope of thisinvention. For example, the route for passage of a suction catheter inmost configurations may as well be used for passage of a stylette foruse in facilitating intubation, for passage of a bronchoscope or thelike. The connection port for the artificial airway for RSR devices canhave a 15 mm inner diameter (ID); however, it could be any ID necessaryto connect with various artificial airway tubes or the like. Theconnection port of the ventilation source can have 15 mm outer diameter;however, it could be any ID necessary to connect with a ventilatorcircuit, closed suction device, or similar device, or may be used opento the atmosphere.

All RSR device embodiments of this invention could be integrated intoother components found in breathing circuits, such as artificialairways, medical instruments (for example suction catheters), HMEs,medication delivery devices, tubing, fittings, etc. Tubing could also beconnected between any ports described in all RSR device embodiments ofthis invention and other components found in breathing circuits. Forexample, tubing, such as flexible tubing, can be connected between theRSR device and the artificial airway and/or a HME. It is also understoodthat many of the RSR device embodiments of the inventions arebi-directional and will function to trap liquid coming from either sideof the RSR device. In fact, with slight modification, all of thedisclosed embodiments could function bi-directionally as would beapparent to one skilled in the art.

Many of the respiratory secretion retention (RSR) devices discussedabove include an instrument port for receiving a medical instrument,e.g., a catheter of a closed suction device, a catheter of an opensuction device, a bronchoscope, a drug delivery device, and the like. Inembodiments, the instrument port can be configured on a RSR device sothat the artificial airway is still closed to the atmosphere even whenthe medical instrument is not present. For example, plugs 320 and 322shown in FIGS. 3A and 3B respectively can accomplish this.Alternatively, a valve could be used to maintain a closed system. Forexample, when a medical instrument is not present, a valve can beconfigured so it remains in a closed state. When a medical instrument isinserted, the valve can open to allow the medical instrument to enterinto and/or through the RSR device. Various valve types configured toallow passage in one direction can be utilized, e.g., a flapper valve, acheck valve, a biased valve, a pucker valve, a duckbill valve and thelike. Also, valves that open when a certain pressure is reached (i.e.“cracking pressure”) can be utilized, such as a valve that activateswhen medication is introduced via a syringe that is connected to an RSRdevice.

In illustration, FIG. 18A is a cross-sectional view of anotherembodiment of an RSR device 1800 according to the present invention.Housing 1802 can include an instrument port 1840 for receiving a medicalinstrument, a patient port 1820 for connection to an artificial airwayand a ventilation port 1830 for connection to a closed suction deviceand/or ventilation source (not shown). Housing 1802 also can have areservoir 1804 for collection of respiratory secretions. In embodiments,housing 1802 can be similar to housing 705 of RSR device 700 to allowfor conformational change in terms of the alignment of the instrumentport 1840 with certain other parts of the structure of the RSR device1800. RSR device 1800 further can include a valve 1842 located in theinstrument port 1840. In FIG. 18A, the valve 1842 is shown in a closedposition or state. FIG. 18B illustrates a medical instrument 1812, e.g.,a closed suction device connected to the instrument port 1840. FIG. 18Cillustrates catheter 1810 of the closed suction device 1812 insertedthrough valve 1842. Valve 1842 is shown in an open position or state.Referring again to FIG. 18B, RSR device 1800 also can have a fluidinstillation port 1862. Fluid may be instilled through port 1862 tolavage or clean a portion of the medical instrument 1812, such as aportion of catheter 1810 of a closed suction device 1812. Closed valve1842 prevents the fluid from entering portions of the RSR device thatare closed to the atmosphere during this cleaning process. Referringagain to FIG. 18A, ventilation port 1830 could be at an angle, forexample 45 or 90 degrees, or could be parallel to the patient port 1820.Any of the ports 1820, 1830, or 1840 could have swivels as discussed inprevious RSR device embodiments. Features such as a diverter, which weredescribed in other embodiments of this invention, may also be located inthe RSR device 1800 to further separate secretions from the gas flow.Features and methods for clearing an RSR device of respiratorysecretions described in other embodiments of this invention, drainports, and/or or suction ports may also be located in the RSR device1800. Also, other RSR device embodiments discussed in the presentinvention could have a valve, a fluid instillation port, and/orventilation port.

FIG. 19A illustrates another embodiment of an RSR device. RSR device1900 can include a housing 1902, which can include a patient port 1920,a ventilation port 1930, an instrument port 1940 and a rotatable housingsection 1904. All three ports 1920, 1930 and 1940 can have swivelconnectors. The instrument port 1940 can include a control valve 1942,as described in other embodiments, which controls access to reservoir1950 and maintains a closed system to atmosphere. The patient port 1920and the ventilation port 1930 are configured to extend sufficiently farinto reservoir 1950 of RSR device 1900 to prevent the unintendedemptying or displacement of liquid contents from the reservoir 1950 intoan artificial airway of a patient or into the ventilation deliverybranch or limb. In FIG. 19A, the ventilation port 1930 and theinstrument port 1940 are shown parallel to each other. The instrumentport 1940 and the patient port 1920 can be aligned so a medicalinstrument 1910 can enter into the reservoir 1950 of RSR device 1900 andtravel through to the patient port 1920. Instrument port 1940 can berepositioned as shown in FIG. 19B, to enable a medical instrument 1910to enter the reservoir 1950 at a different angle. The different anglecan facilitate the removal of the fluid contents 1956 by use of medicalinstrument 1910, such as a suction catheter. FIG. 19C furtherillustrates a cross-sectional perspective view of RSR device 1900. Therotatable housing section 1904 can include a first connecting section1906 and a second connecting section 1908. In operation, as rotatablehousing section 1904 is rotated downward from a first position to asecond position, the two connecting sections 1906 and 1908 maintain asealed connection with the inner wall of housing 1902. The sealedconnection will insure that no fluid contents 1956 escape from reservoir1950.

FIG. 20A illustrates another embodiment of an RSR device. RSR device2000 can include a housing 2002, which can include a patient port 2020,a ventilation port 2030 and an instrument port 2040. All three ports2020, 2030 and 2040 can have swivel connectors. The instrument port 2040can include a control valve 2042 as described in other embodiments. Thepatient port 2020 and the ventilation port 2030 are configured to extendsufficiently far into reservoir 2050 of the RSR device 2000 to preventthe unintended emptying or displacement of liquid contents from thereservoir 2050 into an artificial airway of a patient or into theventilation delivery branch. Patient port 2020 and ventilation port 2030may be on the same plane as shown in FIG. 20A or may be on differentplanes similar to the patient and ventilation ports of RSR device 1900.In this embodiment, it is preferred that the ventilation port 2030 andthe instrument port 2040 be angled relative to each other to allowadequate clearance between a medical instrument 2012 and a ventilatorcircuit (not shown). This angle may facilitate the setup of theventilator circuit. For example, as illustrated in FIG. 20A, theventilation port 2030 and the patient port 2020 are at a substantially90 degree angle of orientation to each other. The instrument port 2040and the patient port 2020 can be aligned so the medical instrument 2010could enter into RSR device 2000 and move through the patient port 2020.FIG. 20B illustrates RSR device 2000 in a tilted position, which canallow the fluid contents 2056 to shift towards the instrument port 2040.A catheter 2010 of suction device 2012 is illustrated removing the fluidcontents 2056 from the reservoir 2050. If additional secretions enterthe reservoir 2050 through the patient port 2020 and splash the topsurface of the fluid contents, the angled relationship between theventilation port 2030 and the patient port 2020 makes it less likelythat any liquid contents will splash into the ventilation port 2030. Inembodiments, a drain or an additional port can be included in anotherportion of the RSR device 2000 to allow for further removal of theliquid contents of reservoir 2050. In embodiments, a flexible tube (notshown) may be connected between the patient port 2020 and the artificialairway. In embodiments, a flexible tube (not shown) may be connectedbetween ventilation port 2030 and the ventilation circuit (not shown).Flexible tubes connected to a RSR device can facilitate the setup of theventilator circuit, as well as facilitate repositioning a RSR device.

Each of the RSR device embodiments described in this specification canhave a housing portion with a fitting portion. FIG. 21 illustrates a RSRdevice 2100 that is similar to RSR device 1800. RSR device 2100 includesa housing portion 2102 and a fitting portion 2104. Housing 2102 caninclude a patient port 2120 and a connection port 2110. The housing 2102is designed to retain secretions as described in previous embodiments.In embodiments, the patient port 2120 and the connection port 2110 canhave swivel connectors. Connected to the connection port 2110 is afitting portion 2104 of RSR device 2100. The fitting portion 2104 caninclude an instrument port 2140 for receiving a medical instrument. Thefitting portion 2104 also can include a ventilation port 2130.Ventilation port 2130 can be affixed to the fitting portion 2104 at anangle, for example 30 or 90 degrees, or can be parallel to any otherport. One or more of ports 2110, 2130, 2140 on the fitting portion 2104can have swivel connectors as discussed in previous RSR deviceembodiments. Similar to RSR device 1800, RSR device 2100 may include avalve 2142 located within the instrument port and can include a fluidinstillation port 2162. In embodiments, fitting portion 2104 could be aseparate part. In embodiments, a tube may be positioned between orinstead of the fitting portion 2104 of RSR device 2100. Additionalfeatures such as a diverter (not shown), which are described in otherembodiments of this invention, also can be located in the RSR device2100 to further separate secretions from the gas flow. FIG. 21 alsoillustrates a suction tube assembly 2154 that serves as a drain port forRSR device 2100. Suction tube assembly 2154 can be connected to asuction device to clear the RSR device of any contained respiratorysecretions. Suction tube assembly 2154 may be capped or pluggedexternally (not shown) when suction is not required. Suction tubeassembly 2154, which is mounted to housing 2102, may be repositioned bytranslation, rotation, or both to facilitate removal of secretions fromreservoir 2150. Suction tube assembly 2154 may have an angled tipportion to allow it to access different areas of RSR device 2100 whensuction tube assembly 2154 is repositioned. Any embodiment of thisinvention can have a drain port similar to the suction tube assembly2154.

FIG. 22A illustrates another embodiment of an RSR device. RSR device2200 can include a housing 2202, which can include a patient port 2220,a ventilation port 2230 and an instrument port 2240. Any of the ports2220, 2230, or 2240 could have swivel connectors as discussed inprevious RSR device embodiments. In embodiments, housing 2202 caninclude a side cavity 2252 configured to assist in the removal of liquidcontents of reservoir 2250. In FIG. 22A, the instrument port 2240 isshown in a coaxial alignment with the patient port 2220; however, thetwo ports can be in a non-coaxial alignment as well. In this embodiment,the patient port 2220 and the ventilation port 2230 are provided withpivoting features, for example ball and socket joints, which allow forthe rotation of the housing 2202 without exerting undue stress on anyattached artificial airway tubing or ventilation tubing connected topatient port 2220 and ventilation port 2230, respectively. For example,as the housing 2202 is rotated downward, the side cavity 2252 translatesto a substantially downward orientation, as illustrated in FIG. 22B, andthe fluid contents 2256 of reservoir 2250 collect in side cavity 2252. Amedical instrument 2210, e.g., a suction catheter, can be insertedthrough the instrument port 2240 and introduced to into side cavity 2252to allow the removal of the liquid contents, e.g., secretions from thereservoir 2250. In FIG. 22B, repositioning of the RSR device 2200 isactuated by use of ball and socket joints at the patient and ventilationports 2220, 2230. In other embodiments, repositioning can be actuated byuse of translating fittings, swivels (single axis or multiple axes)and/or other rotational and translational mechanisms located at thepatient and ventilation ports 2220, 2230. Even though the housing 2202is shown repositioned in FIG. 22B, the patient port 2220 and theventilation port 2230 are still oriented as in FIG. 22A and are stilloriented at the same angle with respect to one another. This allows thehousing 2202 to be repositioned without affecting the artificial airwayor the ventilation circuit. In embodiments, patient port 2220,ventilation port 2230, and/or housing 2202 may have features to maintaina desired position with respect to one another, such as lockingfeatures, and/or features to limit range of repositioning.

FIG. 23A illustrates another embodiment of an RSR device. RSR device2300 can include a housing 2302, which can include a patient port 2320and an access port 2330 that can function as both a ventilation port andan instrument port. Any of the ports 2320 or 2330 could have swivelconnectors as discussed in previous RSR device embodiments. Inembodiments, housing 2302 can include a suction tube assembly 2354,which is mounted to the housing 2302 and connected to an actuationmechanism 2370, such as a knob, a dial, a button or the like, thatprovides for repositioning of the suction tube assembly 2354 within thehousing 2302 by rotation, translation or other means of motion.Referring again to FIG. 23A, a medical instrument 2310, e.g., acatheter, passes through a passage 2372 of the suction tube assembly2354 and through the patient port 2320 into an artificial airway. In asecond position, the catheter 2310 can couple with a suction tubeportion 2374 of the suction tube assembly 2354 such that suction isdirected to the bottom of the reservoir 2350 to drain the fluid contents2356. In embodiments, suction tube portion 2374 could have a funnelshaped entrance to facilitate entry of the catheter. In embodiments,suction tube portion 2374 could have a valve or membrane that sealsaround the catheter when it is inserted into the suction tube portion.FIG. 23B illustrates the suction tube assembly 2354 positioned tosuction the reservoir 2350. Suction tube assembly 2354 and/or actuationmechanism 2370 may be locked into a certain position(s) if desired.

FIG. 24 illustrates another embodiment of an RSR device. RSR device 2400can include a housing 2402, which can include a patient port 2420 and anaccess port 2430 that can function as both a ventilation port and aninstrument port. Any of the ports 2420 or 2430 could have swivelconnectors as discussed in previous RSR device embodiments. Inembodiments, housing 2402 can include a suction tube assembly 2454,which is mounted within the housing 2402. Referring to FIG. 24A, amedical instrument 2410, e.g., a catheter, passes through a passage 2456(FIG. 24B) and a valve 2442 of the suction tube assembly 2454 andthrough the patient port 2420 into an artificial airway. In a secondposition, as illustrated by FIG. 24B, the catheter 2410 can couple witha suction tube fluid removal portion 2458 of the suction tube assembly2454 such that suction is directed to the bottom of the reservoir 2450to drain the fluid contents 2456. In this embodiment, the medicalinstrument 2410 is not extended through the valve 2442, which remainsclosed, but is seated near the top of the suction tube fluid removalportion 2458 to suction the fluid contents 2456 of reservoir 2450.Suction tube assembly 2454 could have at least one additional valve ormembrane 2444 that seals around the catheter when it is inserted intothe suction tube assembly. In embodiments, suction tube assembly 2454could have a funnel shaped entrance to facilitate entry of the catheter.An additional port may be included in the RSR device to removesecretions.

FIG. 25A illustrates another embodiment of an RSR device. RSR device2500 can include a housing 2502, which can include a patient port 2520and an access port 2530 that can function as both a ventilation port andan instrument port, and a tube 2560 coaxially aligned and positionedbetween the patient port 2520 and the access port 2530. Any of the ports2520 or 2530 could have swivel connectors as discussed in previous RSRdevice embodiments. Tube 2560 can include a diverter 2514 that isattached to an inner bottom wall at a hinge point 2516 to the tube 2560.In embodiments, diverter 2514 can attach along any portion of the innerwall of tube 2560 at any hinge point or points. The tube 2560 furthercan include a first opening or aperture 2562 and second opening oraperture 2564 in the top and bottom walls, respectively, of tube 2560.First aperture 2562 and second aperture 2564 can be located near themidpoint of tube 2560 on opposing walls. In embodiments, the aperturescould be located at any point and on any wall of tube 2560 as long asthe apertures are on different sides of the diverter. As illustrated inFIG. 25A, the flow diverter 2514 is in a first position, where the fluidexpirations from the patient port 2520 can strike flow diverter 2514 andexit tube 2560 via second aperture 2564 into reservoir 2550 where theliquids are retained while the gases flow around the outside of tube2560 and reenter tube 2560 via first aperture 2562, and then flow on toaccess port 2530. FIG. 25B illustrates when a medical instrument 2510,e.g., a catheter, is inserted into access port 2530, to pass throughtube 2560, the catheter can force the flow diverter 2514 into an openposition allowing the medical instrument to access patient port 2520 andany artificial airway connected to patient port 2520. In embodiments,patient port 2520 and access port 2530 are coaxially aligned. Inembodiments, flow diverter 2514 can be pushed into an open position viaa manual operation. Manual operation could be accomplished by a button,switch, knob, or other means of mechanical operation. By pushing theflow diverter into an open position or going through the flow diverter,a medical instrument 2510, e.g., a suction catheter can be passed fromthe access port 2530 into the artificial airway. In embodiments, theflow diverter 2514 can also be configured in such a way so as to allowthe medical instrument 2510 to pass through it as discussed in previousembodiments. For example, diverter 2514 could be a valve. Inembodiments, the diverter 2514 may redirect the medical instrument intothe reservoir 2550, for example to suction the reservoir of retainedsecretions. Other features and methods for clearing an RSR device ofrespiratory secretions described in other embodiments of this invention,including drain ports and/or or suction ports may also be located in theRSR device 2500.

FIG. 26A illustrates a cross-sectional perspective view of anotherembodiment of an RSR device. RSR device 2600 can include a housing 2602,which can include a patient port 2620, a ventilation port 2630, and aninstrument port 2640. Any of the ports 2620, 2630, or 2640 could haveswivel connectors as discussed in previous RSR device embodiments. Inembodiments, housing 2602 can include a suction tube assembly 2654,which is mounted to the housing 2602 and connected to an actuationmechanism 2670, such as a knob, a dial, a button or the like, thatprovides for repositioning of the suction tube assembly 2654 within thehousing 2602 by rotation. FIGS. 26B and 26C illustrate cross-sectionsthrough the patient port 2620. Referring to FIG. 26B, a medicalinstrument 2610, e.g., a catheter passes through a passage 2672 of thesuction tube assembly 2654 and through the patient port 2620 into anartificial airway. In a second position as illustrated in FIG. 26C, thecatheter 2610 can couple with a suction tube portion 2674 of the suctiontube assembly 2654 such that suction is directed to the bottom of thereservoir 2650 to drain the fluid contents 2656. FIG. 26C illustratesthe suction tube assembly 2654 rotated relative to its position in FIG.26B in order to suction the reservoir 2650. Suction tube assembly 2654and/or actuation mechanism 2670 may be locked into a certain position(s)if desired.

In the position illustrated in FIG. 26B, the suction tube assembly 2654itself also can function as a diverter to further separate secretionsfrom the gas flow. In all embodiments of this invention that have afeature to divert secretions from the gas flow, an actuation mechanismsuch as actuation mechanism 2670 could be provided to the RSR device toallow for repositioning of the diverter feature. For example, RSR device1600 has a diverter 1620 that is shown in the gas flow path. Anactuation mechanism may be connected to diverter 1620 that allows thediverter to be repositioned to a new position where it is not in the gasflow path. This new position could facilitate the insertion of a medicalinstrument through the RSR device by allowing the medical instrument togo around diverter 1620 instead of through diverter 1620.

As previously discussed, all of the RSR device embodiments in thisinvention may be located at any point in the breathing circuit in orderto protect either the downstream (towards the patient) or upstream(towards the ventilation source) circuit components from patientsecretions or any other liquid in the circuit. For example, a RSR devicecan be placed between a closed suction system and an HME or ventilatorcircuit, as illustrated in FIG. 27A. RSR device 2700 is connectedbetween closed suction system 2706 and HME 2708. It is understood thatthe RSR device can be connected to other components found in breathingcircuits, such as tubing, fittings (e.g., wyes, tees, connectors,elbows, adapters and spacers), medication delivery device, etc. Alsoshown are an artificial airway 2702 and a ventilator circuit 2704. Inthis embodiment, RSR device 2700 may have a port 2760 located on thehousing for the removal of fluids which have been trapped by the device.FIG. 27B, a cross-sectional view of RSR device 2700, illustrates thatthe RSR device may include a patient side port 2720, a ventilator sideport 2730, and a reservoir 2750. The RSR device may also include adiverter 2714, similar to diverters described in other embodiments ofthis invention. RSR device 2700 may have spill guards 2726 which preventpatient secretions from reentering the circuit once they are trapped.Both ports 2720 and 2730 may include swivel connectors as discussed inprevious RSR device embodiments.

As previously discussed, all of the RSR device embodiment of thisinvention may include drain ports to facilitate removal of respiratorysecretions. Drain ports may include a valve for the application ofsuction. The actuation of the valve could be via insertion of a medicalinstrument, manual user operation as with a push button valve, byautomated electrical operation as with a computer controlled solenoidvalve, or any other suitable means of actuation.

FIG. 28 illustrates another embodiment of an RSR device. RSR device 2800can include a housing 2802, a patient port 2820, a ventilation port2830, a tube 2832, which can defined patient port 2820 and ventilationport 2830 and one or more drain ports 2860. Any of the ports 2820 or2830 could have swivel connectors as discussed in previous RSR deviceembodiments. Housing 2802 can have a reservoir 2850 for collection offluids. Housing 2802 can contain a tube 2832 that has a plurality ofholes 2846. The holes 2846 can take any shape or configuration such thatfluid may pass through the holes 2846 and into reservoir 2850. Assecretions move through tube 2832, air pressure and/or gravity can forcethe secretions out through holes 2846 and into reservoir 2850. Housing2802 can be configured in a conical shape, which can aid in theretention and clearance of secretions from the reservoir 2850. Gravitycan aid in the movement of secretions through the reservoir towards adrain port 2860. Secretions can be drained or suctioned through the atleast one drain port. In this embodiment, a plurality of drain portsincreases the number of positions that RSR device 2800 may be cleared ofsecretions. As discussed previously, any or all of the drain ports couldinclude a control valve (not shown). In embodiments, holes 2846 arepositioned in such a way as to create an area above and below the holesfor secretions to accumulate in reservoir 2850 for when RSR device 2900is positioned with the axis of tube 2832 in a vertical orientation. Thisprevents unintended emptying of secretions from reservoir 2850 back intotube 2832.

FIG. 29A illustrates a cross-sectional perspective view of an embodimentof an RSR device. RSR device 2900 includes a tube 2932 (best shown inFIG. 29B), which defines a patient port 2920 and a ventilation port2930. Any of ports 2920 or 2930 can have swivel connectors as discussedin previous RSR device embodiments. RSR device 2900 also includeshousing 2902 attached to tube 2932, which defines drain port 2960 andfluid instillation port 2965. Housing 2902 can be comprised of aflexible material such as thin plastic. Sleeve 2942 surrounds tube 2932and has sleeve slots 2944. Referring to the cross-section illustrated inFIG. 29B, tube 2932 is also shown to have slots, tube slots 2934. Slots2934 and 2944 can take any shape or configuration such that fluid couldpass through the slots and could be considered as holes or the like. RSRdevice 2900 is configured such that the sleeve 2942 may be rotatedangularly with respect to the tube 2932. This rotation can allow sleeveslots 2944 to reposition relative to tube slots 2934 into two distinctconfigurations. FIG. 29B shows a configuration where sleeve slots 2944and tube slots 2934 are aligned. FIG. 29C shows a configuration wheresleeve slots 2944 and tube slots 2934 are not aligned. Referring to FIG.29B, in this configuration is the RSR device 2900 can trap liquids suchas patient secretions. As secretions travel through tube 2932, airpressure and/or gravity can force the secretions out through both tubeslots 2934 and sleeve slots and into reservoir 2950. Referring to FIG.29C, this configuration is configured to facilitate clearing retainedsecretions from the reservoir 2950. Sleeve 2942 blocks tube slots 2934and therefore shields the interior of tube 2932 from the contents of thereservoir 2950. Secretions can be drained or suctioned through the drainport 2960. The instillation of fluid, such as saline, through the fluidinstillation port 2965 can facilitate clearing of secretions. When tubeslots 2934 are blocked, instilled fluids, liquids, secretions,atmosphere, etc., cannot enter the tube 2932. Housing 2902 may also berepositioned or manipulated, such as by squeezing, to aid in movingsecretions through the reservoir and towards drain port 2960. Inembodiments, a flexible housing 2902 may aid in clearing secretions whensuction is applied as the reservoir 2950 may decrease in size and pushthe secretions towards drain port 2960. In embodiments, slots 2934 and2944 are configured in such a way as to limit their length, therebycreating an area above and below the slots 2934 and 2944 for secretionsto accumulate for when RSR device 2900 is positioned with the axis oftube 2932 in a vertical orientation. This further prevents unintendedemptying of secretions from reservoir 2950 back into tube 2932. Inembodiments, sleeve 2942 may be repositioned with respect to tube 2932by any means such as translation, rotation, etc. In embodiments, sleeve2942, tube 2932, and/or housing 2902 may have features that maintain adesired position with respect to one another, such as locking features,and/or features to limit the range of repositioning.

FIGS. 30A and 30B illustrate another embodiment of an RSR device. RSRdevice 3000 can include a housing 3002, which can include a patient port3020, a ventilation port 3030, a reservoir 3050 defined by housing 3002,and a drain port 3060. RSR device 3000 can include tube portions 3070,which can be flexible to increase the utility of the device, e.g. byreducing the stresses in the circuit. Ports 3020 and 3030 can haveswivel connectors as discussed in previous RSR device embodiments. Inthis embodiment, swivel connectors are particularly desirable, becausethe swivel connectors allow the positioning of the drain port 3060 in adownwards orientation thereby facilitating draining of trappedsecretions or other fluids. In addition, if flexible tube portions 3070are present, these flexible tube portions can also assist in positioningthe device for draining. Tube portions 3070 may be integral to thehousing 3002 or may be attached to housing 3002. If the tube portions3070 are attached to the housing 3002, it is preferred for theattachment points to have swivel connectors. As discussed previously,drain port 3060 may include an integral valve to facilitate applyingsuction to the reservoir. As illustrated in the cross-sectional viewFIG. 30B, the reservoir 3050 has a dog-bone shape to facilitate theentrapment of secretions. RSR device 3000 also may contain a diverter3008 as described in previous embodiments. FIG. 30C illustrates anotherconfiguration similar to RSR device 3000. RSR device 3001 has a patientport 3021, a ventilation port 3031, a reservoir 3051 defined by housing3003, and a drain port 3061. RSR device 3001 can include a single tubeportion 3071. Ports 3021 and 3031 can have swivel connectors asdiscussed in previous RSR device embodiments. For example, port 3021 isshown having a swivel connector 3023. Having a single tube portionfurther reduces the deadspace of the RSR device. RSR device 3001 mayhave a diverter 3009 as described in previous embodiments. A baffle typeof diverter system with more than one diverter, which can be angled, isshown as one example.

FIG. 31A illustrates another embodiment of an RSR device. RSR device3100 has a housing 3102. Housing 3102 may be rigid to maintain a“horseshoe” shape whereby secretions can be trapped in severallocations. Housing 3102 may also be flexible to allow for somerepositioning or adjustability of shape. RSR device 3100 may include apatient port 3120, a ventilation port 3130, and one or more drain ports3160. Ports 3120 and 3130 can have swivel connectors as discussed inprevious RSR device embodiments. In this embodiment, swivel connectorsare desirable as they allow positioning of the device to maximizesecretion collection. FIG. 31B illustrates secretions 3156 trapped inRSR device 3100 in one orientation. FIG. 31C illustrates secretionstrapped in RSR device 3100 in a second orientation. FIG. 31D illustratessecretions 3156 trapped in RSR device 3100 in a third orientation. Asshown in FIG. 31D, RSR device 3100 can have a curved housing to furtherincrease the retention of respiratory secretions within the RSR device.

FIG. 32A illustrates another embodiment of an RSR device. RSR device3200 can include a housing 3202 which defines a tube portion and aplurality of grooves 3206. The RSR device also includes a patient port3220 and a ventilation port 3230, and one or more drain ports (notshown). Ports 3220 and 3230 can have swivel connectors as discussed inprevious RSR device embodiments. As patient secretions advance withinhousing 3202, the secretions become trapped in the grooves 3206. Grooves3206 can have a depth of 1 mm or greater to become effective fluidtraps. It is also preferred to have at least two grooves if the groovesare individual features, such as circumferential grooves. Inembodiments, the grooves may be formed by one helical feature. Theconfiguration of the grooves also limits the resistance to flow in themain tube portion of housing 3202. RSR device 3200 may be flexibleand/or may be comprised of a flexible material, such as polyethylene,silicone and the like. The flexibility of the RSR device can add to theutility of the device by relieving stresses in the circuit. In addition,the RSR device 3200 may also be comprised of rigid material such aspolycarbonate or polypropylene. In embodiments, RSR device 3200 may havea curved housing to further increase the retention of respiratorysecretions within the RSR device. FIG. 32B illustrates a cross-sectionalview of RSR device 3200. The passive collection of secretions mayfunction in any orientation and may be aided by flexibility in the RSRdevice 3200. In embodiments, RSR device 3200 can have no drain port andsimply can be disposed of after becoming saturated with secretions.

In addition, although not required for function of this invention, theuse of clear materials is desirable as it aids in determining the amountof fluid sequestered in the RSR device. In addition, the RSR device canbe made of or coated with antimicrobial substances or materials toprevent the growth of bacteria, and other microbes, for exampleantimicrobial substances that prevent the formation of biofilms on orwithin the RSR device. Further coatings containing silver or a silveralloy may be used to prevent or decrease the formation of biofilmsand/or inhibit the growth of bacteria on or within the RSR device.Further coatings or materials with hydrophilic properties may be used toimprove the retention of secretions in a reservoir area. Furthercoatings or materials with hydrophobic properties may be used todecrease adhesion of secretions to the diverter or other surfaces in theRSR device. A hydrophobic diverter is more likely to shed tenacioussecretions off the diverter and into the reservoir during high flowventilation.

FIG. 33A illustrates another embodiment of an RSR device. RSR device3300 includes a retention assembly 3302 and suction assembly 3304.Retention assembly 3302 can include a ventilator port 3330, a patientport 3320, connection port 3306 and an optional tube 3332 disposedbetween the patient port 3320 and ventilator port 3330 and in fluidcommunication with a reservoir 3350. Tube 3332 may be collapsible andprovides additional strain relief between the RSR device 3300 and aventilator circuit (not shown). Ports 3320, 3330, and 3306 can haveswivel connectors as discussed in previous RSR device embodiments.Suction assembly 3304 can include a connector 3308 having a fluidinstillation port 3365 and a suction port 3360 in fluid communicationwith the suction assembly 3304 via optional tubing 3313. Suctionassembly 3304 further can include an actuation mechanism 3370, e.g., athumb valve and the like, disposed between tubing 3313 and suction port3360. The actuation mechanism 3370 provides for controlling a hospitalsuction line (not shown) that connects to suction port 3360. Inembodiments, the actuation mechanism 3370 could be engaged or integrateddirectly into connector 3308. As illustrated in FIG. 33A, retentionassembly 3302 and suction assembly 3304 are in a nonassembled stage. Atthe discretion of the user (e.g. when reservoir 3350 has collectedsecretions), the user attaches the suction assembly 3304 to theretention assembly 3302 of the RSR device 3300 via the connection port3306 and the connector 3308 so that suction can be performed on thereservoir 3350 of the RSR device 3300.

FIG. 33B is a perspective view of RSR device 3300 in an assembled stage.FIG. 33B illustrates a cross-section plane labeled A-A. In operation, aclinician can activate the actuation mechanism 3370 to apply suction tothe reservoir 3350. Saline or another fluid that passes through fluidinstillation port 3365 can be used by the clinician to assist in keepingthe suction line from becoming clogged or blocked with secretions.

FIG. 33C is a partial longitudinal cross-sectional view of anonassembled RSR device 3300 taken along the plane labeled A-A shown inFIG. 33B. The connection port 3306 can include an outer wall 3340, whichcan have an annular shape and be configured to engage an outer wall 3348of the connector 3308. Connection port 3306 can include a plug 3344 anda cap 3342. In an embodiment, cap 3342 is attached to the plug 3344 by acap tether 3346. The plug 3344 can have an inner wall 3343. Connector3308 can have a spike 3309, which can be a hollow tube that includes anouter wall and an inner wall that defines a conduit or passageway forthe passage of secretions and other fluids. In embodiments, the tip ofspike 3309 can have a smaller diameter than the base of spike 3309. Thediameter of the hollow tube can increase from a tip portion of spike3309 to the base portion of spike 3309, for example in a sloping manner.As the connector 3308 is advanced towards the connection port 3306, asshown by arrow 3351 of FIG. 33D, the outer wall of spike 3309 willcontact an inner wall 3343 of plug 3344 to create an initial sealingconnection 3347 (FIG. 33D). Sealing connection 3347 advantageouslyprevents exposure of the reservoir 3350 and/or its contents toatmosphere once cap 3342 is pushed away from the plug 3344. Asillustrated by FIG. 33E, the clinician may now further advance connector3308 such that spike 3309 forces cap 3342 to be opened and therebyprovide for the capability to drain or suction the reservoir 3350.

Similar to FIG. 33C, FIG. 34A is a partial longitudinal cross-sectionalview of a nonengaged RSR device 3400. FIG. 34A illustrates an alternatestructure and mode for achieving a seal while engaging a suctionassembly 3404. The connection port 3406 of retention assembly 3402 caninclude an outer wall 3440, which can have an annular shape and beconfigured to engage an outer wall 3448 of the connector 3408 of suctionassembly 3404. Connection port 3406 can have a valve 3442 (e.g., aduckbill valve, a dome valve, spring-loaded valve, and the like) whichprovides a seal for reservoir 3450. FIG. 34B is a partial longitudinalcross-sectional view of a fully engaged RSR device 3400. As theconnector 3408 is advanced towards the connection port 3406, as shown byarrow 3451 of FIG. 34A, the outer surface of spike 3409 will contact thevalve 3442 to create a sealing connection 3447 (FIG. 34B). Sealingconnection 3447 advantageously prevents exposure of the reservoir 3450and/or its contents to atmosphere. Valve 3442 may reseal the reservoir3450 when suction assembly 3404 is removed.

Similar to FIG. 33C, FIG. 35A is a partial longitudinal cross-sectionalview of a nonengaged RSR device 3500. FIG. 35A illustrates an alternatestructure and mode for achieving a seal while engaging a suctionassembly 3504. The connection port 3506 of retention assembly 3502 caninclude an outer wall 3540, which can have an annular shape and beconfigured to engage an outer wall 3548 of the connector 3508 of suctionassembly 3504, and can include a cap 3542 that provides a seal forreservoir 3550. Suction assembly 3504 can have a sealing ring 3544(e.g., an O-ring, gasket, and the like). FIG. 35B is a partiallongitudinal cross-sectional view of a partially engaged RSR device3500. As the connector 3508 is advanced towards the connection port3506, as shown by arrow 3551 of FIG. 35B, the sealing ring 3544 willcontact the inner surface of the outer wall of the connection port 3506to create an sealing connection 3547 (FIG. 35B). Sealing connection 3547advantageously prevents exposure of the reservoir 3550 and/or itscontents to atmosphere once cap 3542 is pushed open. As illustrated inFIG. 35C, the clinician may now further advance connector 3508 such thatspike 3509 forces cap 3542 to be opened and thereby provide for thecapability to drain or suction the reservoir 3550.

Similar to FIG. 33C, FIG. 36A is a partial longitudinal cross-sectionalview of a nonengaged RSR device 3600. FIG. 36A illustrates an alternatestructure and mode for achieving a seal while engaging a suctionassembly 3604. The connection port 3606 of retention assembly 3602 caninclude an outer wall 3640, which can have an annular shape and beconfigured to engage an outer wall 3648 of the connector 3608, and caninclude a membrane 3642 (e.g., a thin film and the like), which providesa seal for reservoir 3650. FIG. 36B is a partial longitudinalcross-sectional view of a fully engaged RSR device 3600. As theconnector 3608 is advanced towards the connection port 3606, as shown byarrow 3651 of FIG. 36A, the outer surface of spike 3609 will contact themembrane 3642 to create an sealing connection 3647 (FIG. 36B). Sealingconnection 3647 advantageously prevents exposure of the reservoir 3650and/or its contents to atmosphere. In embodiments, RSR device 3600 caninclude a sealing ring (not shown) similar to sealing ring 3544 of FIG.35A. In embodiments, spike 3609 may only open or puncture membrane 3642without engaging it in a sealing connection.

Similar to FIG. 33C, FIG. 37A is a partial longitudinal cross-sectionalview of a nonengaged RSR device 3700. FIG. 37A illustrates an alternatestructure and mode for achieving a seal while engaging a suctionassembly 3704. The connection port 3706 of retention assembly 3702 caninclude a valve 3742, which provides a seal for reservoir 3750, and aretention spring 3743 used to bias the valve in a closed position. FIG.37B is a partial longitudinal cross-sectional view of a fully engagedRSR device 3700. As shown by arrow 3751 of FIG. 37B, a suction assembly3704 (FIG. 37B) can be inserted into access port 3709 to move the valve3742 the direction shown by arrow 3751 and thereby open valve 3742 toallow the reservoir 3750 to be drained or suctioned. Suction assembly3704 may form a sealing connection 3747 with port 3709 prior to engagingvalve 3742. Sealing connection 3747 advantageously prevents exposure ofthe reservoir 3750 and/or its contents to atmosphere. Suction assembly3704 may take the form of a syringe and needle (as shown), a catheter, aspike, a lumen, or the like. Valve 3742 can reseal the reservoir 3750when suction assembly 3704 is removed. In embodiments, connection port3706 of retention assembly 3702 can be configured to engage a connector(not shown) of suction assembly 3704, where the connector can be similarto connector 3448 of FIG. 34A. This connector could have a spike (notshown) similar to spike 3409 shown in FIG. 35A that could engage withaccess port 3709.

FIG. 38A illustrates another embodiment of an RSR device. RSR device3800 includes a retention assembly 3802. Retention assembly 3802 caninclude a ventilator port 3830, a patient port 3820, a connection port3806 (FIG. 38B) and an optional tube 3832 disposed between the patientport 3820 and ventilator port 3830 and in fluid communication with thereservoir 3850. Tube 3832 may be collapsible and provides additionalstrain relief between the RSR device 3800 and a ventilator circuit (notshown). Ports 3820, 3830, and 3806 can have swivel connectors asdiscussed in previous RSR device embodiments. Retention assembly 3802can include an actuation mechanism 3870 (e.g., a knob, a dial, a buttonor the like) that provides for repositioning, such as by rotation,translation or other means of motion, of a valve 3842 (FIG. 38B) that ispositioned within the retention assembly 3802.

FIG. 38B is a partial longitudinal cross-sectional view of a retentionassembly 3802 taken along the plane labeled A-A shown in FIG. 38A.Referring to FIG. 38B, the connection port 3806 of retention assembly3802 can be configured to engage a cap 3862, and can include a valve3842 that provides a seal for reservoir 3850. With the valve 3842positioned in a closed position as demonstrated in FIG. 38B, cap 3862can be removed prior to engaging a suction assembly without exposing thereservoir 3850 and/or its contents to atmosphere.

At the discretion of the user (e.g. when reservoir 3850 has collectedsecretions), the user attaches the suction assembly 3804 to theretention assembly 3802 of the RSR device 3800. FIG. 38C is a partiallongitudinal cross-sectional view of an assembled RSR device 3800 takenalong the plane labeled A-A shown in FIG. 38A. The connection port 3806can include an outer wall 3840, which can have an annular shape and beconfigured to engage an outer wall 3848 of the suction assemblyconnector 3808. As the suction assembly connector 3808 is advancedtowards the connection port 3806, as shown by arrow 3851 of FIG. 38C,the inner surface of outer wall 3848 of suction assembly connector 3808will contact the outer wall 3840 of connection port 3806 to create aninitial sealing connection 3847 (FIG. 38C). Sealing connection 3847advantageously prevents exposure of the reservoir 3850 and/or itscontents to atmosphere. As illustrated by FIG. 38C, the clinician maynow open the valve 3842 by activating the actuation mechanism 3870 andthereby provide for the capability to drain or suction the reservoir3850 through a drain port 3860. In operation, a clinician advantageouslynow has the capability to directly control suction (i.e. no suction,less suction, more suction) via the actuation mechanism 3870 and thevalve 3842. The valve 3842 can be closed to reseal the reservoir 3850and then suction assembly 3804 can be removed without exposing thereservoir 3850 and/or its contents to atmosphere.

FIG. 39 illustrates a cross-sectional cutaway view of another embodimentof an RSR device. RSR device 3900 can include a housing 3902, whichdefines a tube portion 3932, and can include an absorbent media 3910that is designed to trap respiratory secretions. The RSR device alsoincludes a patient port 3920 and a ventilation port 3930. Ports 3920 and3930 can have swivel connectors as discussed in previous RSR deviceembodiments. As patient secretions advance within the tube portion 3932of housing 3902, the secretions become trapped in the absorbent media3910. In operation, the absorbent media 3910 provides the clinicianadditional time between circuit changes. For example the clinician canrotate RSR device 3900 to expose fresh absorbent media once one sidebecomes saturated with secretions. RSR device 3900 may be flexibleand/or may be comprised of a flexible material, such as polyethylene,silicone and the like. The flexibility of the RSR device can add to theutility of the device by relieving stresses in the circuit. In addition,the RSR device 3900 may also be comprised of rigid material such aspolycarbonate or polypropylene. RSR device 3900 simply can be disposedof after becoming saturated with secretions. In embodiments, RSR device3900 can have a drain port (not shown) to remove secretions. Inembodiments, RSR device can have a plurality of grooves 3906. Theabsorbent media 3910 can fill the grooves 3906, providing for additionalvolume for holding trapped secretions. Secretions can wick from theportion of the media 3910 nearest the axis of tube 3932 towards theportion of the media 3910 in the grooves. In embodiments, the media maynot fill the grooves 3906 but may just lay over the grooves 3906. Inthis embodiment, the media 3910 is constructed to first initiallycapture the secretions, second to wick the secretions into the grooves3906, and third to not allow the secretions to exit from the grooves(e.g. by trapping due to material properties or nano-sized details inthe media 3910).

FIG. 40 illustrates another embodiment of a RSR device 4000, which issimilar to RSR device 1700. RSR device 4000 includes a housing 4002, apatient side port 4020, and a ventilation side port 4030, and mayinclude a tube 4032. Any of the ports 4020 or 4030 could have swivelconnectors as discussed in previous RSR device embodiments. Housing 4002can have a reservoir 4050 for collection of fluids. Similar to RSRdevice 1700, reservoir 4050 can be made of a flexible material, whichallows the reservoir 4050 to deform and allows the size of the reservoirto be controlled. A drain port 4060 may be included which allows foremptying the contents of the reservoir, such as by suctioning. In oneembodiment, a RSR device 4000 can include a fluid instillation port4065. Instillation port 4065 can be used to instill saline or otherfluid to help clear the respiratory secretions which have collected inthe reservoir, especially if these secretions are thick or heavilyviscous.

A clip 4070 can be applied to the reservoir 4050 to divide the volume ofthe reservoir to an upper area 4052 above the clip 4070 and a lower area4054 below the clip 4070. Clip 4070 can compress reservoir 4050 locally,preventing any of the contents in the upper area 4052 from draining intothe lower area 4054. Clip 4070 is configured so a user can actuate it bypushing or squeezing in order to temporarily allow it to not compressreservoir 4050. During this non-compressed state, contents in the upperarea 4052 could move into the lower area 4054. In one embodiment, clip4070 could have a button 4072 to facilitate this actuation. Any methodor feature known to one skilled in the art that would allow the clip4070 to actuate in a manner that it would not compress reservoir 4050would be suitable.

Actuation of clip 4070 may also allow the user to move the clip 4070 toa different location on the reservoir 4050. This would allow a user toadjust the volume of the upper area 4052 of the reservoir 4050 asdesired. A smaller reservoir volume is advantageous to limit dead spacevolume, especially for example in smaller patients and in patients withcertain respiratory diseases. A larger reservoir volume is advantageousto allow for less frequent clearing of the secretions in the RSR device4000. The position of the clip 4070 may be adjustable on the reservoir,similar to RSR device 1700, and therefore adjusting the volume in theupper area 4052 as desired by the user. Reservoir 4050 may also havemarkings 4056 to indicate different reservoir volumes and deadspace. Inother embodiments features such as a diverter (not shown), which weredescribed in other embodiments of this invention, may also be located inthe RSR device 4000 to further separate secretions from the gas flow anddirect them into the reservoir 4050.

FIG. 41A illustrates another embodiment of a RSR device 4100, whichfunctions similarly to RSR device 2900. RSR device 4100 includes a tube4132, which defines a patient end port 4120 and a ventilation port 4130.Any of ports 4120 or 4130 can have swivel connectors as discussed inprevious RSR device embodiments. RSR device 4100 also includes housing4102 that encloses a first portion 4134 (best shown in FIG. 41B) of tube4132. Housing 4102 can be comprised of a flexible material such as thinplastic.

Referring to cross-sectional view FIG. 41B of RSR device 4100, a firstportion 4134 of tube 4132 is preferably made of a material and designthat allows it to compress axially, such as by collapsing into itselflike a bendable or compressible drinking straw. First portion 4134 canhave apertures 4138. When the first portion 4134 is in its extendedposition, apertures 4138 are open. When the first portion 4134 iscompressed axially, apertures 4138 are sealed against the opposing outerwall of the tubing 4132. Apertures 4138 can take any shape orconfiguration such that a fluid could pass through the apertures andcould be considered as holes or the like. In the position shown in FIG.41B, RSR device 4100 can trap liquids such as patient secretions. Assecretions travel through tube 4132, air pressure and/or gravity canforce the secretions out through apertures 4138 into a reservoir 4150 ofhousing 4102.

In the configuration when the first portion 4134 is compressed axiallyto force apertures 4138 to seal, the RSR device 4100 is configured tofacilitate clearing retained secretions from the reservoir 4150. Sincethe apertures 4138 are sealed, the interior of tube 4132 is shieldedfrom the contents of the reservoir 4150. Secretions can be drained orsuctioned through the drain port 4160. Suctioning the reservoir 4150while the apertures 4138 are sealed, prevents the suctioning procedurefrom affecting the pressure or flows within the tubing 4132. Theinstillation of fluid, such as saline, through a fluid instillation port4165 can facilitate clearing of secretions. When apertures 4138 aresealed, instilled fluids, liquids, secretions, atmosphere, etc., cannotenter the tube 4132. Housing 4102 may also be repositioned ormanipulated, such as by squeezing, to aid in moving secretions throughthe reservoir and towards drain port 4160. In embodiments, a flexiblehousing 4102 may aid in clearing secretions when suction is applied asthe reservoir 4150 may decrease in size and push the secretions towardsdrain port 4160. In embodiments, tube 4132, and/or housing 4102 may havefeatures that maintain a desired position with respect to one another,such as locking features, and/or features to limit the range ofrepositioning. Tubing 4132 may have a second portion 4136 that isexternal to housing 4102. In embodiments, first portion 4134 and secondportion 4136 could be two different tubes. In the extended configurationshown in FIG. 41B, if the housing 4102 is flexible, this may allow theuser to determine the pressure inside the housing 4102 by observing theamount the inflation of the flexible housing. In embodiments, thehousing 4102 may also have markings (not shown) to indicate differentinflation levels that may correlate to different pressures.

FIGS. 42A and 42B illustrate another embodiment of a RSR device 4200.RSR device 4200 includes a housing 4202, a patient side port 4220, and aventilation side port 4230. Any of the ports 4220 or 4230 could haveswivel connectors and/or tubing extensions as discussed in previous RSRdevice embodiments. Housing 4202 can have a reservoir 4250 forcollection of fluids. A drain port 4260 can be included which allows foremptying of respiratory secretions that may collect in the reservoir.Housing 4202 can have a valve 4242 that prevents unintended emptying ofthe reservoir contents. Valves have been discussed previously in otherRSR device embodiments. In embodiments, any feature apparent to oneskilled in the art that prevents unintended emptying of the contentscould be used, such as a thin plastic film.

Methods for emptying the collected respiratory secretions in an RSRdevice have been discussed in other embodiments. Some of these methodsincluded draining, squeezing, and suctioning, such as by a suctiondevice or by a syringe. Once secretions have collected inside RSR device4200, a secretion removal assembly 4204 that includes a bag 4290 may beutilized to collect secretions that emit from the drain port 4260. Bag4290 can be connected to the RSR device 4200 at any time, for example atthe discretion of the user. In one embodiment, bag 4290 may have afitting 4292 and an optional tube 4213. Fitting 4292 can connect todrain port 4260, preferably in a sealing manner. When connected, fitting4292 can open valve 4242. The contact area between the fitting 4292 andvalve 4242 may also create a secondary seal. In other embodiments when afilm is used instead of a valve, the fitting 4292 would pierce the film.Once the bag 4290 is assembled to the RSR device 4200, the secretionscould be transferred from the reservoir 4250 to the bag 4290. When bag4290 is full, it may be removed and discarded without requiring the RSRdevice 4200 to be removed from the ventilation circuit. A new bag may beconnected when needed. In other embodiments, bag 4290 may be permanentlyattached or attached in a non-removable manner. When a valve 4242 isutilized, the valve 4242 will close when bag 4290 is removed andtherefore any additional secretions will be maintained in the reservoir4250 and the inside of the circuit will not be exposed to atmosphere orthe pressures inside of the circuit will not be affected. Bag 4290 canbe made of a rigid or flexible material and can be inflatable. Inembodiments, bag 4290, tube 4213, or fitting 4292 can also have acontrol valve (not shown), such as biased valve, anti-reflux valve, orany other feature previously discussed or commonly known that preventsunintended emptying of the bag contents. In embodiments, tube 4213 couldbe simply clamped (such as by a clamp or clip), pinched, or tied off toprevent unintended emptying of the bag contents.

The collection bag approach presents a method of removing secretionsfrom a RSR device without affecting the pressures inside of the system.Transfer of the secretions from the RSR device 4200 to the bag 4290 mayoccur passively due to gravity or the pressure inside the system. Inembodiments reservoir 4250 may be flexible and allow the user the optionto squeeze the reservoir 4250 to assist in transferring the secretionsinto the bag 4290. In other embodiments, the bag 4290 may have a bagport (not shown) that allows the bag 4290 to be drained or suctioned.This would allow the bag 4290 to be emptied of secretions withoutrequiring it to be removed from the rest of the RSR device 4200. Also,suction applied to bag 4290 may facilitate the transfer of the sectionsfrom the reservoir 4250 to the bag 4290. In yet other embodiments, RSRdevice 4200 can include a fluid instillation port (not shown). A fluidinstillation port can be used to instill saline or other fluid to helpclear or transfer the respiratory secretions which have collected in thereservoir or bag, especially if these secretions are thick or heavilyviscous.

FIG. 43A illustrates another embodiment of a RSR device 4300. RSR device4300 can include a housing 4302 with a patient port 4320 and aventilation port 4330. Any of the ports 4320 or 4330 could have swivelconnectors and/or tubing extensions as discussed in previous RSR deviceembodiments. Housing 4302 can have at least two reservoirs, firstreservoir 4351 and second reservoir 4352, for collection of fluids. Byhaving more than one reservoir, RSR device 4300 can retain moresecretions. Housing 4302 can include an actuation mechanism 4370 (e.g.,a knob, a dial, a button or the like) that provides for repositioning,such as by rotation, translation or other means of motion, of a wall4304 (FIGS. 43B and 43C) that is positioned within the housing 4302.FIGS. 43B and 43C illustrate cross-sections along lines 43-43 throughthe patient port 4320 from a top view. Referring to FIG. 43B, wall 4304is positioned to isolate first reservoir 4351 from the flow path insideof housing 4302. In this configuration, secretions that pass throughhousing 4302 would be retained in the second reservoir 4352. Thedeadspace of RSR device 4300 in this configuration includes the internalvolumes of the housing 4302 and second reservoir 4352. Because firstreservoir 4351 is sealed off by wall 4304, it is not included as part ofthe deadspace. In embodiments, various features known to one skilled inthe art that would allow the flow path to be redirected towards only onereservoir or that isolates one reservoir from the flow path could servethe purpose of wall 4304. Examples of these features include switches,valves, overlapping walls, diverters and the like.

When the second reservoir 4352 is full of secretions, the user mayreposition actuation mechanism 4370 in order to move wall 4304. FIG. 43Cillustrates one example of this process. Wall 4304 has been moved so asto isolate the second reservoir 4352 from the flow path inside ofhousing 4302 and to expose first reservoir 4351 to the flow path. Inthis configuration, secretions that pass through housing 4302 would nowbe retained in first reservoir 4351. The deadspace of RSR device 4300includes the internal volumes of the housing 4302 and first reservoir4351. Since second reservoir 4352 is sealed off by wall 4304, it is notincluded as part of the deadspace in this configuration. This method ofrepositioning wall 4304 allows for a RSR device that has increasedcapacity for secretion retention without increased deadspace.Alternatively, the user may move wall 4304 to a position where it doesnot seal either first reservoir 4351 or second reservoir 4352. In thisconfiguration, both first reservoir 4351 and second reservoir 4352 canretain secretions and can be in the fluid flow path through the RSRdevice 4300. Actuation mechanism 4370 and/or wall 4304 may be lockedinto a certain position(s) if desired.

Referring to FIG. 43A, drain ports 4360 may be included in reservoirs4351 and 4352 to provide for content removal from the reservoirs 4351and 4352 by various methods, such as by suctioning and the like. Theremoval of secretions from a reservoir that it is isolated from the gaspath by wall 4304 (shown in FIGS. 43B and 43C) is advantageous becauseit allows the secretions to be removed without affecting the pressure orfluid flows within the RSR device 4300. Another advantage is that theinside of the circuit will not be exposed to atmosphere during theremoval process. In one embodiment, RSR device 4300 can include a fluidinstillation port (not shown), which can be used to instill saline orother fluid to help clear the respiratory secretions that have collectedin reservoirs 4531, 4532, especially if these secretions are thick orheavily viscous

FIG. 43D illustrates an alternate method of secretion clearance orremoval from RSR device 4300. If the user positions actuation mechanism4370 as shown in FIG. 43B, first reservoir 4351 is isolated from theflow path. The user may now remove first reservoir 4351 from housing4302 without affecting the pressure within the RSR device 4300 andwithout exposing to the inside of the circuit to atmosphere. The usermay now clear first reservoir 4351 of secretions or simply dispose firstreservoir 4351, and then sealingly engage a reservoir back into thevacant reservoir opening in housing 4302. This method of replacing orclearing reservoirs that are not currently in the flow path allows theuser to endlessly clear out secretions without removing the RSR device4300 from the ventilation circuit.

FIG. 44A illustrates another embodiment of an RSR device. RSR device4400 includes a retention assembly 4402 and suction assembly 4404.Retention assembly 4402 can include a ventilator port 4430, a patientport 4420, a connection port 4406 and an optional tube 4432 disposedbetween the patient port 4420 and ventilator port 4430 and in fluidcommunication with the reservoir 4450. Tube 4432 may be collapsible andprovides additional strain relief between the RSR device 4400 and aventilator circuit (not shown). Ports 4420, 4430, and 4406 can haveswivel connectors as discussed in previous RSR device embodiments.Suction assembly 4404 can include a connector 4408 in fluidcommunication with a fluid instillation port 4465 and a suction port4460. Suction assembly 4404 further can include a tubing 4413 and anactuation mechanism (not shown), e.g., a thumb valve and the like,similar to actuation mechanism 3370 of RSR 3300. In embodiments, theactuation mechanism could be coupled or integrated directly intoconnector 4408. The actuation mechanism provides for controlling ahospital suction line (not shown) that fluidly connects to suction port4460. As illustrated in FIG. 44A, retention assembly 4402 and suctionassembly 4404 are in an assembled stage. At the discretion of the user(e.g. when reservoir 3350 has collected secretions), the user attachesthe suction assembly 4404 to the retention assembly 4402 of the RSRdevice 4400 via the connection port 4406 and the connector 4408 so thatsuction can be performed on the reservoir 4450 of the RSR device 4400.

FIG. 44A includes two section planes A-A and B-B that subsequent figuresreference. FIG. 44B shows a cross-sectional perspective view takenthrough plane B-B of RSR device 4400 in an assembled state. This viewillustrates that connection port 4406 includes a plug 4444 that haschannels 4445, which in this configuration allow fluid communicationfrom reservoir 4450 to suction assembly 4404. FIG. 44C is a perspectiveview of plug 4444 of RSR device 4400 and illustrates the channels 4445.

FIGS. 44D, 44E, and 44F illustrate partial cross-sections of RSR device4400 in non-engaged, partially engaged, and fully engaged positionsrespectively. FIG. 44D is a partial longitudinal cross-sectional view ofa nonassembled RSR device 4400 taken along the plane labeled A-A shownin FIG. 44A. The connection port 4406 can include an outer wall 4440,which can have an annular shape and be configured to engage an outerwall 4448 of the connector 4408 of suction assembly 4404, and caninclude a plug 4444. The plug 4444 can include an inner wall 4443.Connector 4408 can include a spike 4409.

FIG. 44E is a partial longitudinal cross-sectional view of a partiallyengaged RSR device 4400 taken along the plane labeled A-A shown in FIG.44A. As the connector 4408 is advanced by the user towards theconnection port 4406, as shown by arrow 4451 of FIG. 44E, the outersurface of spike 4409 will contact the inner wall 4443 of plug 4444 tocreate an initial sealing connection 4447 (FIG. 44E). Sealing connection4447 advantageously prevents exposure of the reservoir 4450 and/or itscontents to atmosphere once plug 4444 is pushed upward further intoreservoir 4450.

FIG. 44F is a partial longitudinal cross-sectional view of a fullyengaged (i.e. assembled) RSR device 4400 taken along the plane labeledA-A shown in FIG. 44A. As the connector 4408 is further advanced towardsthe connection port 4406, as shown by arrow 4451 of FIG. 44F, the spike4409 forces plug 4444 to reposition further into reservoir 4450 andthereby places channels 4445 in fluid communication with the reservoir4450 (as shown in FIG. 44B). In the assembled position, the suctionassembly 4404 can provide for the capability to drain or suction thereservoir 4450. Outer wall 4440 of connection port 4406 and outer wall4448 of connector 4408 can snap together as shown. In embodiments, anymethod or feature for coupling two parts known to one skilled in the artsuch as threads, clips, bands, press fit, etc. could be utilized.Coupling methods or features such as these could apply to any of thesuction assembly and retention assembly embodiments previouslydescribed, such as devices 3400, 3500, 3600, etc. For example, walls4440 and 4448 of RSR device 4400 could have threads (not shown).Depending on the coupling method or feature, the advancement directionof the connector assembly may vary. For example, a press fit connectionof connector 4408 onto connection port 4406 would have an advancementdirection as shown by arrow 4451 of FIG. 44E. However, in an embodimentwhere a threaded connection (not shown) exists between connector 4408and connection port 4406, advancement direction could be best describedby a helical arrow (not shown).

While the invention has been described in terms of what is presentlyconsidered to be the most practical and preferred embodiments, it is tobe understood that the invention needs not be limited to the disclosedembodiment. On the contrary, it is intended to cover variousmodifications and similar arrangements included within the spirit andscope of the appended claims, which are to be accorded with the broadestinterpretation so as to encompass all such modifications and similarstructures.

1-21. (canceled)
 22. A secretion removal assembly configured to connectto a respiratory secretion retention device, the respiratory secretionretention device adapted to fluidly connect to an artificial airway, thesecretion removal assembly comprising: a connector adapted to connect toa port of the respiratory secretion retention device; and, a bag influid communication with the connector.
 23. The secretion removalassembly in claim 22, wherein the bag is adapted to collect thesecretions that emit from the port of the respiratory secretionretention device.
 24. The secretion removal assembly in claim 22,wherein the bag is adapted to be connected to the connector by a userduring use.
 25. The secretion removal assembly in claim 22, wherein thebag is adapted to be connected and disconnected to the connector duringuse.
 26. The secretion removal assembly in claim 22, further comprisinga tube having a first end and a second end opposite the first end, thefirst end in fluid communication with the connector and the second endin fluid communication with the bag.
 27. The secretion removal assemblyin claim 22, wherein the connector sealingly engages at least a portionof the port of the respiratory secretion retention device.
 28. Thesecretion removal assembly in claim 22, wherein the connector sealinglyengages the port of the respiratory secretion retention device withoutopening a reservoir of the respiratory secretion retention device toatmosphere.
 29. The secretion removal assembly in claim 22, furthercomprising a spike coupled to the connector.
 30. The secretion removalassembly in claim 29, wherein the spike is adapted for one of breaching,engaging and repositioning a seal of the port of the respiratorysecretion retention device.
 31. The secretion removal assembly in claim22, further comprising a control valve adapted to control contents ofthe bag.
 32. The secretion removal assembly in claim 22, furthercomprising a clamp to control the contents of the bag.
 33. The secretionremoval assembly in claim 22, further comprising a bag port.
 34. Thesecretion removal assembly in claim 22, wherein the connector is adaptedto first engage the port of the respiratory secretion retention devicein a non-sealed area of the port prior to one of breaching, engaging andrepositioning of a seal of the port of the respiratory secretionretention device.
 35. A secretion removal assembly configured to connectto a respiratory secretion retention device, the respiratory secretionretention device adapted to fluidly connect to an artificial airway, thesecretion removal assembly comprising: a connector adapted to connect toa port of the respiratory secretion retention device; wherein thesecretion removal assembly is adapted to collect the secretions thatemit from the port without the use of suction.
 36. secretion removalassembly in claim 35, wherein the connector is adapted to allow thesecretions to drain into the secretions removal assembly.
 37. Thesecretion removal assembly in claim 35, wherein the connector is adaptedto allow the secretions into the secretions removal assembly by use ofan applied force.
 38. The secretion removal assembly in claim 37,wherein the applied force is generated by a ventilation source.
 39. Thesecretion removal assembly in claim 37, wherein the applied force isgenerated by the user.
 40. The secretion removal assembly in claim 37,wherein the applied force is generated by an instilled fluid.
 41. Arespiratory secretion removal system comprising: a respiratory secretionretention assembly, the respiratory secretion retention assembly adaptedto fluidly connect to an artificial airway; and a secretion removalassembly; wherein the secretion removal assembly comprises a collectionbag.